Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2)
This study is being done to see how safe and effective abemaciclib is when given together
with abiraterone acetate plus prednisone in participants with metastatic castration resistant
prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
• Histologically confirmed adenocarcinoma of the prostate.
• Metastatic prostate cancer documented by positive bone scan and/or measurable soft
tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
• Progressive disease at study entry demonstrated during continuous androgen-deprivation
therapy (ADT)/post orchiectomy defined as one or more of the following:
• PSA progression
• Radiographic progression per Response Evaluation Criteria in Solid Tumors
(RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3)
for bone, with or without PSA progression
• Be able and willing to undergo mandatory tumor biopsy of at least one metastatic site.
• Have adequate organ function.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion Criteria:
• Prior therapy with cytochrome P450 (CYP)17 inhibitors.
• Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6
inhibitors.
• Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer
(participants treated with docetaxel in the metastatic hormone-sensitive prostate
cancer [mHSPC] are eligible), prior radiopharmaceuticals for prostate cancer, or prior
enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior
radiation or surgery to all target lesions.
• Currently enrolled in a clinical study involving an investigational product.
• Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
• Clinically significant heart disease, active or chronic liver disease, moderate/severe
hepatic impairment (Child-Pugh Class B and C).
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific
Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to
increase diagnostic accuracy in localizing primary and metastatic lesions in patients with
suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS)
scores and Prostate-Specific Antigen (PSA).
• Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated
and/or rising PSA) as determined by referring physician
• Patients must have had a diagnostic, standard of care mpMRI of the prostate with at
least one lesion with a PI-RADS v2.1 score ≥ 4
• In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL
• Patients must be scheduled for biopsy or radical prostatectomy
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0-3
• Patients should not have had any type of curative or palliative therapy for prostate
cancer before enrolling in the study
• Patients must be medically stable as judged by the patient's physician
• Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
• Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
• Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot
participate in the study
• Patients who have had a prior biopsy for prostate cancer cannot participate in the
study
• Patients who have been treated for cancers other than skin cancers
• Subjects may not be receiving any other investigational agents for the treatment of
the cancer under study
• Patients may not weigh more than the maximum weight limit for the PET/CT scanner table
(>200 kilograms or 440 pounds)
• History of allergic reactions attributed to compounds of similar chemical or biologic
composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based
intravenous contrast agent used during the mpMRI
• Prior TURP/BPH procedures, including steam/laser therapies
Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
The purpose of this study is to evaluate the safety and efficacy of ARO-HIF2 injection (also
referred to as ARO-HIF2) and to determine the recommended Phase 2 dose in the treatment of
patients with advanced clear cell renal cell carcinoma (ccRCC).
• Women of childbearing potential must have a negative pregnancy test, cannot be
breastfeeding and must be willing to use contraception
• Willing to provide written informed consent and to comply with study requirements
• Histologically confirmed locally advanced or metastatic clear cell renal cell
carcinoma that has progressed during or after two prior therapeutic regimens which
must include vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint
inhibitor therapy or that has otherwise failed such therapies, is measurable disease
per RECIST 1.1 criteria, is biopsy accessible
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Estimated life expectancy of longer than 3 months
• Adequate organ function at screening
Exclusion Criteria:
• History of untreated brain metastasis or leptomeningeal disease or spinal cord
compression
• Failure to recover from reversible effects of prior anticancer therapy
• Has received systemic therapy or radiation therapy within 2 weeks prior to screen
• History of solid organ or stem cell transplantation
• Current use of anti-VEGF or mammalian target of rapamycin (mTOR) agents, or chronic
immunosuppressive therapy
• Any prior use of hypoxia inducible factor 2 (HIF2) inhibitors
• Current use of immune checkpoint inhibitors
• Use of an investigational agent or device within 2 weeks prior to dosing, or current
participation in an investigational study
• Known HIV, hepatitis B or hepatitis C
• History of other clinically meaningful disease
• Major surgery within 4 weeks of Screening
• Active malignancy requiring therapy other than ccRCC within 3 years of study entry
Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
This is a prospective study to determine if the use of curcumin randomized against placebo
will reduce cancer progression in patients with prostate cancer undergoing active
surveillance.
• Age between 40-89 years
• Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)
• May have had biopsy within last 12 months ≤4 cores involved with cancer
• Gleason score ≤6 with no Gleason pattern 4
• Clinical stage T1c-T2a/b
• Serum PSA ≤15 ng/ml
• Life expectancy > 5 years
Exclusion Criteria:
• Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy,
oral glucocorticoids, GnRH analogues, prostatectomy)
• Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor
• Use of anabolic steroids or drugs with antiandrogenic properties
• Prostate volume >150 grams
• Patients who are taking antiplatelet, anticoagulant agents or have a history of a
bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with
close observation
• History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on
stable doses of GERD medication allowed.
• Patients who are currently taking or plan to take Curcumin during the study
• Patients with a history of gallbladder surgery or gallstones will be excluded
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab
followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by
nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread
to other parts of the body. The addition of cabozantinib to the usual treatment may make it
work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may
help the body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread. Chemotherapy drugs, such as cabozantinib, work in different ways to
stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by stopping them from spreading. It is not yet known how well the combination of
cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in
treating patients with renal cell cancer that has spread to other parts of the body.
• STEP I REGISTRATION CRITERIA
• Histologically documented renal cell carcinoma with clear cell component, including
patients who have sarcomatoid features.
• Any metastatic disease, including visceral, lymph node, other soft tissue and bone,
measurable per RECIST 1.1.
• Measurable disease as defined in the protocol.
• Must be intermediate or poor risk patient per International Metastatic Renal Cell
Carcinoma Database (IMDC) criteria (1 or more of the following: Karnofsky performance
status [KPS] < 80, < 1 year from diagnosis [including initial nephrectomy] to systemic
treatment for metastatic disease, hemoglobin less than lower limit of normal [LLN],
corrected calcium concentration greater than upper limit of normal [ULN], absolute
neutrophil count greater than ULN, platelet count > ULN).
• Central nervous system (CNS) disease permitted, if stable and not otherwise causing
symptoms or needing active treatment.
• Karnofsky performance status >= 70%.
• No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not
limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab,
tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting
T-cell co-stimulation or checkpoint pathways. The only exception is for prior
treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or
post-operative trials, as long as > 1 year since completion of systemic therapy.
• No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days]
and prior adjuvant sunitinib > 180 days since completion and prior immunotherapy as
above are allowed).
• No cancer therapy less than 28 days prior to registration; this includes radiation
therapy, except for bone lesions less than 14 days prior to registration. There must
be a complete recovery and no ongoing complications from radiotherapy.
• Not pregnant and not nursing, because this study involves an agent that has known
genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing
potential only, a negative serum or urine pregnancy test done =< 14 days prior to
registration is required.
• Age >= 18 years
• Absolute neutrophil count (ANC) >= 1,500/mm^3.
• Platelet count >= 100,000/mm^3.
• Hemoglobin >= 8 g/dL.
• Calculated (Calc.) creatinine clearance >= 30 mL/min.
• Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1.
• Total bilirubin =< 1.5 x upper limit of normal (ULN).
• Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of
normal (ULN) or < 5 x ULN if hepatic metastases present.
• STEP 2 REGISTRATION ELIGIBILITY CRITERIA
• Successful completion of at least 1 cycle of ipilimumab/nivolumab.
• Resolution of any treatment-related adverse events to grade 1 or less per dose
modification section (this criteria does not include any adverse events [AEs] not
attributable to treatment which are present due to disease). Exceptions for this
criteria include patients receiving replacement hormone treatments (such as
levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for
adrenal insufficiency). Please contact study chair if further discussion is needed.
• No more than 70 days from last dose of ipilimumab/nivolumab.
Exclusion Criteria:
• Active autoimmune disease requiring ongoing therapy.
• Ongoing acute toxicity > grade 2 from previous treatment.
• History of severe allergic, anaphylactic or other hypersensitivity reactions to
chimeric or humanized antibodies.
• History of human immunodeficiency virus (HIV) or active hepatitis B/C, or active
tuberculosis (purified protein derivative [PPD] response without active TB is
allowed).
• Concurrent use of immunosuppressive medication including prednisone above 10 mg daily.
• Uncontrolled adrenal insufficiency.
• Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90
mmHg).
• Major surgery less than 28 days prior to registration.
• Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to
registration.
• Any arterial thrombotic events within 180 days prior to registration.
• Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to
registration.
• Cavitating pulmonary lesions or known endotracheal or endobronchial disease
manifestations.
• Lesions encasing or invading any major blood vessels (this does not include tumor
thrombus extending into/through renal vein/inferior vena cava [IVC]). Patients with
tumor thrombus extending into/through renal vein are considered eligible.
• Moderate of severe hepatic impairment (Child-Pugh B or C).
• Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180
days prior to registration. (Any asymptomatic, treated pulmonary embolism or
asymptomatic, treated deep venous thrombosis > 30 days prior to registration allowed).
• Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms.
• Unstable cardiac arrhythmia within 6 months prior to registration.
• Any gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of
pulmonary hemorrhage =< 90 days prior to registration.
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess,
bowel obstruction, or gastric outlet obstruction within 180 days prior to
registration.
• Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome
within 28 days prior to registration.
• Untreated hypothyroidism, evidence of pancreatitis, history of organ transplant, or
history of congenital QT syndrome.
• Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors
(e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g.,
clopidogrel) within 5 days of registration. Allowed anticoagulants include:
prophylactic use of low-dose aspirin for cardio-protection (per local applicable
guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of
LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban,
apixaban. Allowed also in patients with known brain metastases who are on a stable
dose of the anticoagulant for at least 1 week prior to registration without clinically
significant hemorrhagic complications from the anticoagulation regimen or the tumor.
• Significant cardiac ischemia events (ST elevation myocardial infarction [STEMI] or
non-ST elevation myocardial infarction [NSTEMI]) within 6 months or active NY Heart
Association class 3-4 heart failure symptoms
Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Bone, Sarcomatoid Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Soft Tissues, Stage IV Renal Cell Cancer AJCC v8, Metastatic Malignant Neoplasm in the Viscera, Metastatic Malignant Neoplasm in the Lymph Nodes
• radical prostatectomy for adenocarcinoma of prostate
• pathologically confirmed T1-T3 disease
• no sign of lymph node or metastatic disease
• pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low
risk for pelvic lymph node or metastatic disease and who would not require
confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or
7(T2 disease) and PSA less than 20.
• Eastern Cooperative Oncology Group(ECOG) status 0-2
• adequate renal and liver function as well as bone marrow reserve (measured serum
creatinine <2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x
K/uLL, and hemoglobin ≥ 10 g/dL)
• 30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
• focally positive surgical margins are permitted
• no plan to receive adjuvant hormone or radiation therapy
• PSA at the time of enrollment must be undetectable
• life expectancy of 3 years
Exclusion Criteria:
• must not have exceeded 3 months from time of surgery to enrollment into study
• T3b or T4 or node positive disease
• macroscopic residual disease after surgery
• hormone therapy before surgery
• history of gallbladder problems or gallstones, or biliary obstruction, unless patient
had cholecystectomy
• radiation therapy as primary treatment after surgery
• INR value greater than 1.5
• AST/ALT are equal or greater than 2 times the upper limit of normal
• antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed
with close observation
• history of gastric or duodenal ulcers or untreated hyperacidity syndromes
• patients who are currently taking or plan to take Curcumin during the study
Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C) (POTEN-C)
Reduction of dose to or 'sparing' of neurovascular structures during stereotactic ablative
body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual
potency, while retaining excellent oncologic control and other secondary health-related
quality of life (HRQOL) endpoints.
Primary Objectives:
• To compare the decline in patient health-related quality of life (HRQOL) instrument-defined
erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without
neurovascular sparing
Secondary Objectives:
- Assess acute (within 9 months of treatment) and chronic (>9 months after treatment) SAbR
related GU and GI toxicities, as well as serial impact on HRQOL metrics over time
- Assess biochemical progression free survival, local recurrence, disease-specific
survival
- Evaluate the impact of neurovascular sparing on neurovascular element dose and the
impact of rectal spacer use on neurovascular element sparing
- Evaluate quality of spacer placement and its effect on dose to neurovascular structures
- Evaluate rate local recurrence in the area of sparing adjacent to the neurovascular
elements by biopsy in those with biochemical progression.
- Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be
compared to prior literature.
1. Age ≥ 18 years.
2. Appropriate staging studies identifying patient as AJCC 7th edition clinical stage T1
(a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland. The patient
should not have direct evidence of regional or distant metastases after appropriate
staging studies. See Appendix I for details on AJCC 7th Edition staging criteria.
Histologic confirmation of cancer will be required by biopsy performed within 12
months of registration. T-staging may be assessed by multi-parametric imaging alone if
digital rectal examination was deferred.
3. The patient's Zubrod performance status must be 0-2 (see Appendix II for definition).
4. The Gleason summary score should be less than or equal to 7 [Grade group 1 (Gleason
3+3=6), group 2 (Gleason 3+4=7), and group 3 (Gleason 4+3=7) are allowed]. See
Appendix III for details on definitions. While a template biopsy is recommended, it is
not required in the case of MRI fusion biopsy performed on all dominant MR lesions
(defined as PIRADS v2 4-5).
5. Baseline AUA symptom score ≤19 (see Appendix IV for questionnaire) without need for
maximum medical therapy (specifically, not on tamsulosin 0.8mg daily)
6. EPIC sexual domain composite score 60-100 (see Appendix V)
7. Multi-parametric MRI evaluation of the prostate is required for this study within 12
months of registration. Gross radiographic disease on MRI (defined as PIRADS v2 score
3-5) must be > 5mm at minimum distance from at least one side's neurovascular bundle,
which is typically the closest of the neurovascular elements to the prostate.
8. The serum PSA should be less than or equal to 20 ng/ml within 90 days of registration.
Study entry PSA must not be obtained during the following time frames: (1) 10-day
period following prostate biopsy; (2) following initiation of ADT or anti-androgen
therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days
after discontinuation of dutasteride; (5) within 5 days of a digital rectal
examination.
9. Ultrasound or MRI based volume estimation of prostate gland ≤ 80 grams. Cytoreduction
therapy (finasteride or dutasteride only) may be considered for those with >60 gram
size.
10. All patients must be willing and capable to provide informed consent to participate in
the protocol within the 30 days prior to registration
Exclusion Criteria:
1. Subjects with clinical (digital rectal examination) evidence of extraprostatic
extension (T3a) or seminal vesicle involvement (T3b). MRI evidence of
equivocal/potential but not definite extraprostatic extension is allowed, as long as
it is unilateral and not on the side of the gland proposed for neurovascular element
sparing. In equivocal cases of potential extracapsular extension on MRI only,
discretion is left to the treating physician.
2. MRI evidence of gross disease (defined as PIRADS v2 score 3-5 lesions) ≤5mm of BOTH
neurovascular bundles, which are the most proximate of the neurovascular elements
planned for sparing on this protocol.
3. Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7,
clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy
cores positive for cancer are ineligible.
4. Inability to undergo multi-parametric MRI.
5. Evidence of metastatic disease. Note bone scan is not required for this study given
the low-intermediate NCCN risk cohort to be enrolled.
6. Evidence of clinical nodal involvement of the pelvis. Biopsy is required for lymph
nodes over ≥1.5cm in short-axis measured size.
7. No currently active ADT or anti-androgen therapy at time of registration is allowed.
Further, no more than 3 cumulative months of prior ADT or anti-androgen therapy is
allowed. If either has been used by the patient, there must be a demonstration of
testosterone recovery (>50ng/dL serum blood level), EPIC sexual domain score ≥60, and
at least 1 month between demonstration of testosterone recovery and study registration
(any one measurement of testosterone recovery suffices).
8. Testosterone ≤ 50 ng/dL (any one measurement >50 ng/dL suffices for inclusion) within
90 days of study entry.
9. Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery
for prostate cancer.
10. Subjects who have plans to receive other concomitant or post treatment adjuvant
antineoplastic therapy while on this protocol including surgery, cryotherapy,
conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as
part of the treatment of prostate cancer.
11. Subjects who have undergone previous transurethral resection of the prostate (TURP) or
ablative procedures to the prostate for benign prostatic hyperplasia or other
conditions (i.e. cryotherapy, HIFU).
12. Subjects who have baseline severe urinary symptoms, as defined by AUA symptom score
>19 (alpha-blocker medication allowed except if taking tamsulosin 0.8mg daily at
baseline which indicates compensated severe symptoms and also can affect sexual
function).
13. Subjects who have a history of significant psychiatric illness that would confound
informed consent.
14. Severe, active co-morbidity, defined as follows:
1. Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months
2. Myocardial infarction within the last 6 months
3. Acute bacterial or fungal infection requiring intravenous antibiotics at time of
registration
4. Patients with active inflammatory colitis (including Crohn's Disease and
ulcerative colitis) currently requiring systemic steroids and/or systemic
immunosuppression are not eligible.
15. Subjects with a known allergy to polyethylene glycol hydrogel (rectal spacer material)
or contraindication to spacer products (SpaceOAR)
16. Subjects with uncontrolled coagulation disorder which cannot be controlled with
anticoagulants
17. Men of reproductive potential who do not agree that they will use an effective
contraceptive method.
18. Men who require erectile function medication or aid to achieve an erection sufficient
for intercourse. Ability to achieve erection sufficient for intercourse without
medication or aid at least once time in the month prior to registration is sufficient
for inclusion.
19. Men who have clinically significant penile malformation (i.e. Peyronie's disease) or
history of penile implantation are excluded
20. If DRE is performed, patient may not have palpable disease on side of gland to be
planned for neurovascular sparing. Given the poor accuracy of DRE, such a finding
should be confirmed by MRI and/or biopsy to harbor actual disease before excluding a
patient
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)
Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive
disease features will receive salvage radiation therapy and standard androgen deprivation
therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free
survival when enhanced ADT is used compared to standard ADT.
• Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy
performed within 10 years prior to registration and any type of radical prostatectomy
is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
• PSA level (≥ 0.2 ng/mL) within 90 days prior to registration. GnRH analog may be
started no more than 42 days prior study entry, but patients must have a PSA ≥ 0.2
ng/mL prior to starting ADT.
• Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days
prior to registration.
• Platelet count ≥ 75,000 x 10^9/µL independent of transfusion and/or growth factors
within 90 days prior to registration.
• At least 1 of the following aggressive features:
• Gleason score of 8-10 (note any Gleason score is eligible)
• Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a
pT stage
≥ pT3b is considered aggressive)
• Locoregional node involvement at radical prostatectomy (pN1)
• Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after
radical prostatectomy
• Serum albumin ≥ 3.0 g/dL within 90 days prior to registration
• GFR ≥35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine
creatinine within 90 days prior to registration.
• Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total
bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin
is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within
90 days prior to registration.
• Testosterone >50 ng/dL within 90 days prior to registration. Prior androgen
deprivation (GnRH analog and/or non-steroidal antiandrogen) therapy is allowed
provided that serum testosterone concentration must be ≥ 50 ng/dL prior to
registration or starting ADT, whichever occurs first; 5-alpha reductase inhibitors
will not impact eligibility, but must be discontinued prior to starting protocol
treatment.
• History and physical with ECOG Performance Status 0-1 or within 90 days prior to
registration.
Exclusion Criteria:
• Definitive clinical or radiologic evidence of metastatic disease with the exception of
locoregional lymph nodes.
• Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of
the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely
resected melanoma) unless disease free for a minimum of 2 years).
• Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a
different cancer is allowable.
• Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields.
• History of any of the following:
• Documented inflammatory bowel disease
• Transmural myocardial infarction within the last 4 months prior to registration.
• New York Heart Association Functional Classification III/IV within 4 months prior
to registration.
• Unstable angina and/or congestive heart failure requiring hospitalization within
the last 4 months prior to registration
• History of loss of consciousness or transient ischemic attack within 12 months
prior to randomization
• History of seizure disorder or condition that may predispose to seizure (e.g.
prior cortical stroke or significant brain trauma)
• History of uncontrolled hypertension defined as a sustained systolic blood
pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess
of 90 mmHg despite optimized antihypertensive therapy.
• History of repeated falls and fractures over the past 12 months that in the
opinion of the treating investigator would put the patient at risk for poor bone
outcomes from androgen receptor targeted therapy
• Known gastrointestinal disorder affecting absorption of oral medications.
• Active uncontrolled infection defined as an identified infectious condition that
requires active therapy that has not yet been completed.
• HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to
registration OR HIV patients under treatment with highly active antiretroviral therapy
(HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV
testing is not required for eligibility for this protocol as it is self-reported. This
exclusion criterion is necessary because the treatments involved in this protocol may
be immunosuppressive and/or interact with HAART.
Radiation: Radiation Therapy, Drug: Enzalutamide, Drug: Bicalutamide, Drug: GnRH analog
RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers (RAVENS)
This is a Phase II non-blinded randomized study evaluating men with oligometastatic prostate
cancer lesions randomized (1:1) to stereotactic ablative radiation therapy (SABR) versus SBAR
+ Radium-223. We are looking to determine the progression-free survival of men who have
oligometastatic prostate cancer with at least one bone metastasis with stereotactic ablative
radiation therapy (SABR) versus SABR + Radium-223.
• Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the
bone or soft tissue (with at least one bone metastasis) develop within the past
6-months that are ≤ 5.0 cm or <250 cm3
• Patient must have had their primary tumor treated with surgery and/or radiation.
• Histologic confirmation of malignancy (primary or metastatic tumor).
• PSADT <15 months. PSA doubling time (PSADT) will be calculated using as many PSA
values that are available from time of relapse (PSA > 0.2). To calculate PSADT, the
Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used.
It can be found at the following web site:
https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
• Patient may have had prior systemic therapy and/or ADT associated with treatment of
their primary prostate cancer. Patient may have had ADT associated with salvage
radiation therapy (to the primary prostate cancer or pelvis is allowed).
• PSA > 0.5 but <50.
• Testosterone > 125 ng/dL.
• Patient must be ≥ 18 years of age.
• Patient must have a life expectancy ≥ 12 months.
• Patient must have an ECOG performance status ≤ 2.
• Patient must have normal organ and marrow function as defined as:
Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥
1.5 x 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL.
* Patient must have the ability to understand and the willingness to sign a written
informed consent document.
Exclusion Criteria:
• No more than 3 years of ADT is allowed, with the most recent ADT treatment having
occurred greater than 6 months prior to enrollment.
• PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that
demonstrate more disease lesions than baseline CT/Bone Scan
• Castration-resistant prostate cancer (CRPC).
• Spinal cord compression or impending spinal cord compression.
• Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
• Patient receiving any other investigational agents.
• Patient receiving abiraterone and prednisone.
• Patient is participating in a concurrent treatment protocol.
• Serum creatinine > 3 times the upper limit of normal.
• Total bilirubin > 3 times the upper limit of normal.
• Liver Transaminases > 5-times the upper limit of normal.
• Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
• Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
• Refusal to sign informed consent.
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)
The primary objective of this study is to compare overall survival (OS) in patients with
progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best
supportive/best standard of care versus patients treated with best supportive/best standard
of care alone.
Key secondary objectives are an arm-to-arm comparison of the following:
- Radiographic progression-free survival (rPFS)
- Response Evaluation Criteria in Solid Tumors (RECIST) response
- Time to a first symptomatic skeletal event (SSE)
Additional Secondary Objectives:
- Safety and tolerability of 177Lu-PSMA-617
- Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short
Form (BPI-SF))
- Health economics
- Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen
[PSA] progression-free survival)
- Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate
dehydrogenase [LDH] levels will also be measured.
1. Patients must have the ability to understand and sign an approved ICF.
2. Patients must have the ability to understand and comply with all protocol
requirements.
3. Patients must be ≥18 years of age.
4. Patients must have an ECOG performance status of 0 to 2.
5. Patients must have a life expectancy >6 months.
6. Patients must have histological, pathological, and/or cytological confirmation of
prostate cancer.
7. Patients must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the
sponsor's central reader.
8. Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7
nmol/L).
9. Patients must have received at least one NAAD (such as enzalutamide and/or
abiraterone).
10. Patients must have been previously treated with at least 1, but no more than 2
previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2
cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is
eligible if: a. The patient's physician deems him unsuitable to receive a second
taxane regimen (e.g. frailty assessed by geriatric or health status evaluation,
intolerance, etc.).
11. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at
least 1 of the following criteria:
1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a
previous reference value measured at least 1 week prior. The minimal start value
is 2.0 ng/mL.
2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter
(SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all
target lesions based on the smallest SOD since treatment started or the
appearance of one or more new lesions.
3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone
scan (2+2 PCWG3 criteria, Scher et al 2016).
12. Patients must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone
scan imaging obtained ≤28 days prior to beginning study therapy.
13. Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities
related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
14. Patients must have adequate organ function:
a. Bone marrow reserve:
• White blood cell (WBC) count ≥2.5 x 10^9/L (2.5 x 10^9/L is equivalent to 2.5 x
10^3/μL and 2.5 x K/μL and 2.5 x 10^3/cumm and 2500/μL) OR absolute neutrophil
count (ANC) ≥1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/μL and 1.5 x
K/μL and 1.5 x 10^3/cumm and 1500/μL)
• Platelets ≥100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/μL and 100 x
K/μL and 100 x 10^3/cumm and 100,000/μL)
• Hemoglobin ≥9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) b. Hepatic:
• Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For
patients with known Gilbert's Syndrome ≤3 x ULN is permitted
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR
≤5.0 x ULN for patients with liver metastases c. Renal:
• Serum/plasma creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min
15. Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) [Inclusion #16 has been removed]
17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are
included in this trial.
18. For patients who have partners of childbearing potential: Partner and/or patient must
use a method of birth control with adequate barrier protection, deemed acceptable by the
principle investigator during the study and for 6 months after last study drug
administration.
19. The best standard of care/ best supportive care options planned for this patient:
1. Are allowed by the protocol
2. Have been agreed to by the treating investigator and patient
3. Allow for the management of the patient without 177Lu-PSMA-617
Exclusion Criteria:
1. Previous treatment with any of the following within 6 months of randomization:
Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body
irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological
therapy [including monoclonal antibodies]) within 28 days prior to day of
randomization.
3. Any investigational agents within 28 days prior to day of randomization.
4. Known hypersensitivity to the components of the study therapy or its analogs.
5. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or
investigational therapy.
6. Transfusion for the sole purpose of making a subject eligible for study inclusion.
7. Patients with a history of CNS metastases must have received therapy (surgery,
radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not
receiving corticosteroids for the purposes of maintaining neurologic integrity.
Patients with epidural disease, canal disease and prior cord involvement are eligible
if those areas have been treated, are stable, and not neurologically impaired. For
patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline
and subsequent radiological imaging must include evaluation of the brain (MRI
preferred or CT with contrast).
8. A superscan as seen in the baseline bone scan.
9. Symptomatic cord compression, or clinical or radiologic findings indicative of
impending cord compression.
10. Concurrent serious (as determined by the Principal Investigator) medical conditions,
including, but not limited to, New York Heart Association class III or IV congestive
heart failure, history of congenital prolonged QT syndrome, uncontrolled infection,
known active hepatitis B or C, or other significant co-morbid conditions that in the
opinion of the investigator would impair study participation or cooperation.
11. Diagnosed with other malignancies that are expected to alter life expectancy or may
interfere with disease assessment. However, patients with a prior history of
malignancy that has been adequately treated and who have been disease free for more
than 3 years are eligible, as are patients with adequately treated non-melanoma skin
cancer, superficial bladder cancer.
Drug: 177Lu-PSMA-617, Other: Best supportive/best standard of care
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of
ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients
with solid tumors undergoing routine surgery.
• Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled
to undergo surgical resection
• Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or
breast cancer
• Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer,
prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
• Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
Exclusion Criteria:
• Histologically diagnosed by an excisional biopsy procedure
• Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging
would not be feasible
• Life expectancy <12 weeks
• Hepatic impairment (Child-Pugh score >5) or significant liver disease including active
hepatitis or cirrhosis
Drug: ONM-100
Prostate Cancer, Non-Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, Ovarian Cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma, Breast - Female, Colon, Ovary, Prostate
Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, the RadiCaL Study
This phase II trial studies whether adding radium-223 dichloride to the usual treatment,
cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the
bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer
cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by
blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and
cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to
the bone, compared to cabozantinib alone.
• Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes
of RCC are eligible including but not limited to clear cell, papillary, chromophobe,
translocation, collecting duct carcinoma, medullary carcinoma, and unclassified
categories. Enrollment of non-clear cell patients will be limited to 20% of the total
sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients
will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and
rhabdoid differentiation are allowed
• Presence of at least 2 metastatic bone lesions not treated with prior radiation is
required
• The presence of bone metastases can be detected by computed tomography (CT),
magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission
tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging.
Patients with non-measurable bone-only disease are allowed. Patients may have
received prior radiation therapy for bone metastases or other external radiation
>= 14 days prior to registration, as long as they still have at least 2
metastatic bone lesions that were not treated with radiation. Patients with
visceral metastases are allowed, as long as they have at least two untreated bone
metastases
• No more than 2 prior lines of systemic therapy including but not limited to
anti-angiogenic therapy, checkpoint inhibitors, mammalian target of rapamycin (mTOR)
inhibitors, clinical trial compounds or cytokine-based therapy. Prior radiation
therapy does not count as a prior systemic therapy
• No prior treatment with cabozantinb
• No treatment with any type of small molecular kinase inhibitor (including
investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is
shorter) of registration or receipt of any anti-cancer therapy (including
investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of
registration
• No prior hemibody external radiotherapy
• No prior therapy with radium-223 dichloride or systemic radiotherapy (such as
samarium, strontium)
• No major surgery within 6 weeks of randomization. Procedures such as thoracentesis,
paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye
surgery are not considered major surgery. Patients who have had a nephrectomy may be
registered >= 3 weeks after surgery, providing there are no wound-healing
complications. Subjects with clinically relevant ongoing complications from prior
surgery are not eligible
• Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any
prior treatment, unless adverse events are clinically nonsignificant and/or stable on
supportive therapy
• The use of osteoclast targeted therapy including either bisphosphonates or denosumab
is mandated on this study except in patients with contraindications as determined by
the treating investigator, including:
• Hypocalcemia
• Hypophosphatemia
• Renal impairment including those with a glomerular filtration rate (GFR) < 35
mL/min using the Cockcroft-Gault equation or acute renal impairment
• Hypersensitivity to drug formulation
• Dental condition or need for dental intervention that per the investigator
would increase the risk of osteonecrosis of jaw (ONJ).
• Use of osteoclast targeted therapy or reason against use needs to be
recorded in the electronic case report form (eCRF). Additionally, reason for
discontinuation of osteoclast targeted therapy need to be appropriately
documented in the eCRF
• Not pregnant and not nursing, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn
are unknown.
• Therefore, for women of childbearing potential only, a negative urine pregnancy
test done =< 28 days prior to registration is required. A female of childbearing
potential is a sexually mature female who: 1) has not undergone a hysterectomy or
bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least
12 consecutive months (i.e., has had menses at any time in the preceding 12
consecutive months)
• Karnofsky performance status >= 60%
• Symptomatic bone pain defined as either regular use of analgesic medication for cancer
related bone pain (>= level 1; World Health Organization [WHO] ladder for cancer pain)
or prior SSE defined as bone pain requiring radiation, bone pain secondary to a
pathologic fracture related to a bone metastasis, symptomatic spinal cord compression
related to a bone metastasis, surgery to bone secondary to symptomatic bone metastasis
or radiographic progression of bone metastases as defined by the presence of bone
metastases on radiographic imaging
• No brain metastases or cranial epidural disease unless adequately treated with
radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to
registration as documented by MRI or CT imaging or deemed stable by clinical
investigator. Treated brain metastases are defined as having no ongoing requirement
for steroids and no evidence of progression or hemorrhage after treatment for at least
4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by
clinical investigator
• No imminent or established spinal cord compression based on clinical symptoms and/or
imaging. In patients with untreated imminent or established spinal cord compression,
treatment with standard of care as clinically indicated should be completed at least 2
weeks before registration
• No imminent or impending pathologic fracture based on clinical symptoms and/or
imaging. In patients with untreated imminent or impending pathologic fracture,
treatment with standard of care as clinically indicated should be completed at least 2
weeks before registration
• No significant, uncontrolled intercurrent or recent illness, including but not limited
to the following conditions:
• Cardiovascular disorders: Symptomatic congestive heart failure, unstable angina
pectoris, serious cardiac arrhythmia; uncontrolled hypertension defined as
sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite
optimal antihypertensive treatment; stroke (including transient ischemic attack),
myocardial infarction, or other ischemic event, within 6 months before
randomization; thromboembolic event (e.g., deep venous thrombosis, pulmonary
embolism) within 1 month before randomization; screening Fridericia's correction
formula (QTcF) =< 500 msec
• Gastrointestinal disorders: Disorders associated with a high risk of perforation
or fistula formation: active inflammatory bowel disease, active diverticulitis,
active cholecystitis, active symptomatic cholangitis or active appendicitis,
active acute pancreatitis or active acute obstruction of the pancreatic or
biliary duct, or active gastric outlet obstruction; abdominal fistula,
gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess
within 3 months before randomization. Note: Complete healing of an
intra-abdominal abscess must be confirmed before randomization
• No clinically significant hematuria, hematemesis, or hemoptysis, or other history
of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before
randomization
• No lesions invading major pulmonary blood vessels
• No other clinically significant disorders:
• Human immunodeficiency virus (HIV)-infected patients on effective
anti-retroviral therapy (with no medications prohibited by this protocol
[e.g. drug-drug interactions]) with undetectable viral load within 6 months
are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the
HBV viral load must be undetectable on suppressive therapy (with no
medications prohibited by this protocol [e.g. drug-drug interactions]), if
indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been
treated and cured. For patients with HCV infection who are currently on
treatment, they are eligible if they have an undetectable HCV viral load
(with no medications prohibited by this protocol [e.g. drug-drug
interactions])
• No serious non-healing wound or ulcer
• No malabsorption syndrome
• No uncompensated/symptomatic hypothyroidism
• No moderate to severe hepatic impairment (Child-Pugh B or C)
• No requirements for hemodialysis or peritoneal dialysis
• No history of solid organ transplantation
• No chronic concomitant treatment with strong CYP3A4 inducers or inhibitors. Because
the list of these agents is constantly changing, it is important to regularly consult
a frequently updated medical reference. Patients may not have received a strong CYP3A4
inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7
days prior to registration
• No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin
inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet
inhibitors (e.g., clopidogrel). Allowed anticoagulants include:
• Prophylactic use of low-dose aspirin for cardio-protection (per local applicable
guidelines) and low-dose low molecular weight heparins (LMWH).
• Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors
rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who
are on a stable dose of the anticoagulant for at least 1 week before first dose
of study treatment without clinically significant hemorrhagic complications from
the anticoagulation regimen or the tumor.
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 10 g/dl (transfusions allowed)
• Calculated (calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault
equation
• Total bilirubin =< 1.5 x upper limit of normal (ULN), for patients with Gilberts
disease =< 3.0 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
• Urine protein to creatinine (UPC) ratio =< 1 mg/mg OR 24-hr urine protein < 1g
Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With mCRPC
A study to evaluate the safety and tolerability of AMG 160 and in combination with
pembrolizumab in adult subjects with metastatic castration-resistant prostate cancer (mCRPC),
and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
• Subject has provided informed consent prior to initiation of any study-specific
activities/procedures
• Subjects with histologically or cytologically confirmed mCRPC who are refractory to a
novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have
failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically
unsuitable to be treated with a taxane regimen or have actively refused treatment with
a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the
non-metastatic CRPC setting
• Subject should have undergone bilateral orchiectomy or should be on continuous
androgen-deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH)
agonist or antagonist
• Total serum testosterone = 50 ng/dL or 1.7 nmol/L
• Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
PSA level >/=1 ng/mL that has increased on at least 2 successive occasions at least 1 week
apart, nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications,
and/or appearance of 2 or more new lesions in bone scan
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 •1
• Life expectancy >/=6 months
Exclusion Criteria:
• Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not
including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue
(agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for
>/= 30 days prior to randomization are eligible
• Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed
with Amgen medical monitor prior to enrollment)
• Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord
compression
• Active autoimmune disease or any other diseases requiring immunosuppressive therapy
while on study
• Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or
equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis
factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
• Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication,
and/or symptomatic congestive heart failure (New York Heart Association > class II)
within 12 months of first dose of AMG 160
Part 2 only:
• Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher
immune-related adverse event prior to first day of dosing
• History or evidence of interstitial lung disease or active, non-infectious pneumonitis
Part 3 only:
-Evidence of active tuberculosis on chest radiograph within 3 months prior to the first
dose of investigational product
Part 6 only:
Subjects are excluded from this cohort if any of the following additional criteria apply:
• Subjects taking strong OAT3 inhibitors (eg, probenecid) or adjust the dosing to 1 mg
PO QD.
• Subjects with latent or active tuberculosis at screening
The Effects of Low Dose Ketamine on Cardiovascular Function
Low dose ketamine is used for pain management and for the treatment of anxiety and
depression. Prior studies on low dose ketamine have noted short-term (minutes to hours)
increases or decreases in blood pressure. Blood pressure that is too high or too low can be
problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure.
In fact, no prior studies have measured sympathetic nervous system activity after low dose
ketamine has been given to an adult. Because sympathetic nervous system activity has a large
influence on blood pressure, we need to know how exactly low dose ketamine affects these body
systems. Therefore, in this research we will study how low dose ketamine affects sympathetic
nervous system activity and cardiovascular function. The results from this research will
inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and
blood vessels.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04429685
STU-2019-1792
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Non-obese (body mass index less than 30 kg/m2)
*alternatively, individuals will be permitted to participate if they have a body mass
index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102
cm for males
• Systolic blood pressure <140 mmHg
• Diastolic blood pressure <90 mmHg
Exclusion Criteria:
• Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
• Current or previous use of anti-hypertensive medications
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Individuals with a history of drug abuse
• Individuals who have an unexplained positive urine drug screen (e.g., some agents
cause false-positive results, but when the agent is abstained for hours/days/weeks,
the repeated drug screen is negative. One example could be an over-the-counter
supplement)
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine
We are examining how morphine (a commonly used pain medication) will alter responses to
simulated blood loss in humans. To simulate blood loss in our research laboratory,
participants will complete a test with their lower body in a custom-designed vacuum chamber
for a brief period of time.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04138615
STU 092017-070
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
Exclusion Criteria:
• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Positive urine drug screen
• Currently taking pain modifying medication(s)