Prostate Cancer

Condition: Prostate Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT04995198

Sponsor: Prostate Cancer Clinical Trials Consortium

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following:
• tissue biopsy, and/or
• PSA greater than 100 ng/dL (1ng/ml), and/or
• clear radiographic evidence of disease
• Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)

Exclusion Criteria:

• Unable or unwilling to provide all of the necessary information for eligibility
• Incomplete inclusion criteria

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05948657

Sponsor: Weill Medical College of Cornell University

Eligibility:

• Age: minimum 18 Years maximum 90 Years
• Gender: Male

Inclusion Criteria:

• Males aged ≥ 18.
• Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
• PSA < 20 ng/ml.
• Ability to undergo yearly PSMA-PET CT.
• Ability to undergo yearly prostate mpMRI.
• Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
• Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
• Willingness to undergo yearly prostate biopsies.

Exclusion Criteria:

• History of prior treatment for prostate cancer.
• History of systemic therapy for prostate cancer.
• Inability to undergo transrectal ultrasound.
• Life expectancy less than 10 years.
• Not interested in pursuing active surveillance.

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Condition: Prostate Cancer, Renal Cancer, Urethral Cancer, Advanced Solid Tumor, Metastatic Castration-resistant Prostate Cancer, Solid Tumor, Adult

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05888532

Sponsor: Rahul Aggarwal

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. 1.

Disease Characteristics:

• by cohort, as defined by: Cohort A:
• Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
• Locally advanced or metastatic disease on conventional imaging Cohort B:
• Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
• Locally advanced or metastatic disease on conventional imaging Cohort C:
• Histologically-confirmed prostate adenocarcinoma
• Metastatic castration resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria 2. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only) 3. Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only) 4. The subject is able and willing to comply with study procedures and provide signed and dated informed consent. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Age 18 years or older at the time of study entry. 7. Adequate organ function, as defined by:
• Serum creatinine <= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance > 60 mL/min
• Total bilirubin <= 1.5 x ULN (< 3 x ULN in patients with documented or suspected Gilbert's).
• Hemoglobin >= 8.0 g/dL
• Platelet count >= 75,000/microliter
• Absolute neutrophil count ≥ 1000/microliter 8. Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of PET Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.

Exclusion Criteria:

1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
3. Is currently pregnant or breastfeeding.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04662580

Sponsor: Ambrx, Inc.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Key Inclusion Criteria:

• Male subjects ≥ 18 years at the first time of providing written informed consent.
• Histologically confirmed prostate adenocarcinoma.
• Documented metastatic disease and evidence of disease progression
• Castration-resistant prostate cancer defined as surgical or medical castration with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) at Screening. For patients who have not undergone an orchiectomy, must be undergoing treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist and must agree to continue such therapy while on study treatment.
• Prior receipt of the following for metastatic prostate cancer:
• at least two lines of treatment
• at least two Food and Drug Administration (FDA)-approved therapies with at least one being a second-generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide).
• Adequate blood counts

Key Exclusion Criteria:

• Use of chronic systemic glucocorticoids equivalent to > 10 mg prednisone daily. Note: short-term administration of systemic corticosteroids > 10 mg prednisone equivalent (e.g., for allergic reactions or management of immune- or infusion-related AEs) is allowed.
• Symptomatic and/or untreated central nervous system (CNS) metastases. Patients with asymptomatic, untreated CNS metastases are eligible provided they have been clinically stable (neurologically stable and not requiring steroids for at least 28 days prior to enrollment).
• History of any invasive malignancy (other than primary) within the previous 2 years prior to the enrollment date that requires active therapy or is at high risk of recurrence in the opinion of the investigator.
• Marked baseline prolongation of QT/QT interval corrected for heart rate (QTc), e.g., a triplicate-average QTc interval > 480 milliseconds (CTCAE Grade 2) using Fridericia's QT correction formula at any time within 28 days before enrollment, ongoing history of CTCAE Grade ≥2 QTc at enrollment, or anticipated need to perform repeat ECG evaluations to satisfy re-treatment criteria.
• Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months prior to enrollment date,
• Clinically significant ocular findings by a qualified ophthalmologist or optometrist including active ocular infections or chronic corneal disorders unless approved by the Medical Monitor.
• Peripheral neuropathy Grade ≥ 2 within 28 days prior to enrollment.

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Condition: Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04335682

Sponsor: Alliance Foundation Trials, LLC.

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Key Inclusion Criteria:

• include:
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Progressive disease per PCWG3 criteria with EITHER: Metastatic CRPC or non- metastatic CRPC (M0CRPC)
• For mCRPC: metastatic disease documented by standard or novel imaging techniques
• OR for M0CPRC: no evidence of metastatic disease on standard imaging.
• OR mHSPC
• Surgically or medically castrated, with testosterone levels of <50 ng/dL. If the patient is medically castrated, continuous dosing with GnRH agonist or antagonist must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Able to complete cognitive testing and patient reported outcome surveys in English.
• Ability to swallow study medications whole.
• Able to provide informed consent.

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Condition: Advanced Solid Tumor, Castration-Resistant Prostatic Cancer, Malignant Melanoma, Pancreatic Ductal Carcinoma, Hepatocellular Cancer, Epithelial Ovarian Cancer, Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05293496

Sponsor: MacroGenics

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 1. Ability to provide and document informed consent and willing and able to comply with all study procedures.
• Participants diagnosed with advanced solid tumors including but not limited to metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma.
• Participants have received approved therapies according to their diagnosis.
• Participants must have an available tumor tissue sample. A fresh tumor biopsy may be performed if no archival sample is available.
• Eastern Cooperative Oncology Group performance status of less than or equal to 2.
• Life expectancy of at least 12 weeks.
• Evidence of measurable tumor for evaluation
• Acceptable end organ function according to laboratory results.
• Patients must agree to use highly-effective contraception during the study, and not donate sperm or ova.

Exclusion Criteria:

• Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
• Another malignancy that required treatment within the past 2 years. Participants who have had curative therapy for non-melanomatous skin cancer, localized prostate cancer (Gleason score < 6), or carcinoma in situ are eligible for the study.
• Active viral, bacterial, or fungal infection requiring systemic treatment within 1 week of initiation of study drug. Participants are eligible after SARS CoV 2-related symptoms have fully recovered for ≥ 72 hours.
• History of immunodeficiency. Participants with HIV are eligible if they have a CD4+ count ≥ 300/µL, undetectable viral load, and maintained on antiretroviral therapy for a minimum of 4 weeks.
• Prior autologous/allogeneic stem cell or tissue/solid organ transplant
• Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer.
• Clinically significant cardiovascular disease, lung compromise, venous insufficiency, or gastrointestinal disorders.
• Participants with greater than Grade 1 peripheral neuropathy.
• Participants who have a history of severe adverse events (AEs) from immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or CTLA-4 inhibitors). All other AEs from prior immune checkpoint inhibitors must be resolved to Grade 1 or less. Participants with any grade neurologic toxicity from prior immune checkpoint inhibitors are excluded.
• Pleural effusion or ascites. Trace pleural or peritoneal fluid is not exclusionary.
• History of Guillain-Barre syndrome, myasthenia gravis, or other autoimmune sensory or motor neuropathies.

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Condition: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Metastatic Castration-resistant Prostate Carcinoma, Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05113537

Sponsor: Vadim S Koshkin

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 1. Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation. 2. Age >= 18 years. 3. Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria. 4. Patients must have adenocarcinoma histology. 5. Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc. 6. Prior treatment with at least one line of taxane-based chemotherapy administered in either the hormone sensitive or castrate-resistant setting. Patients must have recovered (CTCAE grade =< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to study entry. A washout period of at least 21 days is required between last chemotherapy dose and treatment initiation 7. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L) 8. Patients must have a 68Ga-PSMA-11 PET scan with at least 3 PSMA-positive lesions (maximum standardized uptake value [SUVmax] greater than SUVmax of liver) as determined by nuclear medicine review prior to start of lead-in treatment with abemaciclib 9. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 10. Patients must have life expectancy of > 6 months 11. Patients must have adequate organ function as outlined below and bone marrow reserve
• White blood cell (WBC) > 2.5
• Absolute neutrophil count (ANC) > 1.5
• Hemoglobin (Hgb) > 8.0 [Note- Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion]
• Platelets (Plt) > 100,000
• Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =< 2 ULN and direct bilirubin within normal limits is permitted
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =< 3 X institutional upper limit of normal (=< 5.0 ULN for patients with liver metastases)
• Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =< 3 X institutional upper limit of normal (=< 5.0 ULN for patients with liver metastases)
• Creatinine =< 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) >= 50 mL/min/1.73 m, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 12. Patient must be able to swallow oral medications 13. Patients must have the ability to understand a written informed consent document, and the willingness to sign it 14. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial 15. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated 16. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load 17. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial 18. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 2 months following the last dose of study treatment. Effective method of contraception means male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, or cervical cap with spermicide

Exclusion Criteria:

1. Patients with small cell or neuroendocrine carcinoma histology.
2. Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue
3. Patients with prior treatment with CDK4/6 inhibitors
4. Patients with previous treatment with PSMA-targeted radioligand therapy
5. Patients with previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to study entry
6. Any systemic anti-cancer therapy within 3 weeks of study entry
7. Patients who have experienced significant radiation-related adverse events (AEs) from prior radiation treatment (>= grade 3) or have experienced persistent radiation-related AEs that have not resolved by the time of study randomization
8. Patients with prior radiation treatment to lungs or liver
9. Patients with a history of central nervous system (CNS) metastases are ineligible unless they have received prior therapy (surgery, radiation therapy (RT), gamma knife) and are, asymptomatic, and not receiving corticosteroids for this indication. Head imaging is not required
10. Patients with symptoms of cord compression or impending cord compression
11. Patients with concurrent serious medical conditions as determined by primary investigator
12. Patients with other significant malignancies that are expected to alter life expectancy or interfere with disease assessment. Patients with adequately treated skin cancer, non-muscle-invasive bladder cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible. Patients with history of in-situ/early stage melanoma will not be excluded
13. Patients who have not recovered from adverse events due to prior anti-cancer therapy to =< grade 1 or baseline (other than alopecia or peripheral neuropathy)
14. Patients with serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance < 30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
15. The patient has active systemic bacterial infection (requiring intravenous (IV) antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment
16. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
17. Patients currently receiving any other investigational therapeutic agents.

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Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05917470

Sponsor: Oncternal Therapeutics, Inc

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Subject is ≥18 years of age
• Subject has histologically documented metastatic adenocarcinoma of the prostate confirmed by biopsy without neuroendocrine differentiation or small cell features.
• Subjects has a history of metastatic CRPC.
• Subject has R/R disease following treatment with at least one next-generation AR-signaling inhibitor.
• Subject has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or evaluable bony disease. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
• Subject has an Eastern Cooperative Oncology Group performance status of 0,1 or 2, and life expectancy of ≥ 6 months.
• Subject agrees to take or continue luteinizing hormone-releasing hormone agonist or antagonist therapy or has undergone bilateral orchiectomy.
• At least 2 weeks or five half-lives have elapsed, whichever is earliest, since last systemic therapy, including taxanes or other chemotherapy. At least one month has elapsed since systemic therapy with radionuclide pharmaceutical agents
• Subject has evidence of disease progression on or after their most recent systemic treatment
• Subject has a PSA level ≥ 10 ng/mL, or ≥ 2 ng/mL and ≥ 50% increase from nadir on prior therapy, whichever is lowest.
• Subject has serum testosterone < 50 ng/dL.
• Subject has adequate renal, hepatic, and pulmonary function
• Subject is committed to practice true abstinence, or use a highly effective method of contraception with any female partner of childbearing potential unless documented to be surgically sterile (i.e., vasectomy or bilateral orchiectomy) and to not make semen donations during the study and for 3 months after the last dose of study drug.

Exclusion Criteria:

• Subject has small cell prostate cancer or neuroendocrine disease histology, including mixed histology.
• Subject has metastases to the brain or central nervous system
• Subject is receiving concurrent anti-cancer therapy (including chemotherapy, antibody therapy, immunotherapy, cellular therapy, or other experimental therapies) except for ongoing androgen inhibiting therapy such as luteinizing hormone-releasing hormone (LHRH) agonists. Supportive non-cancer directed therapies such as bisphosphonates or denosumab are allowed.
• Subjects taking a strong inhibitor of CYP3A4 or a substrate of CYP2C9 or CYP2C19
• Subject had major surgery within 30 days prior to start of study drug.
• Subject has current, untreated pathologic long-bone fractures(s), or risk of imminent pathologic fracture(s).
• Subject has current or imminent spinal cord compression.
• Subject has an active seizure disorder or a history of seizure disorder(s).
• Subject has evidence of active human immunodeficiency virus infection, hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Subject has any other serious illness or medical condition that would interfere with study participation
• Subject has abnormal electrocardiograms (ECGs) that are clinically significant, including average QTcF > 450 ms, or a history of Torsade de Pointes.
• Subject has any infection requiring parenteral antibiotic therapy or causing fever (temperature >100.5°F or 38.1°C) within 1 week prior to first dose.
• Clinically significant other malignancy with the potential to confound study assessments, with the exception of e.g., treated cutaneous squamous cell and basal carcinomas, non-muscle invasive bladder cancer, Rai Stage 0 CLL, and adequately treated Stage 1 to 2 non-cutaneous malignancy in remission for 5 years.
• Subject is unable to comply with the protocol and/or not willing or not available for follow-up assessments
• Subject has any medical intervention or other condition which, in the opinion of the Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.

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Condition: Metastatic Castration-Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06318273

Sponsor: AbbVie

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
• Estimated life expectancy > 6 months.
• Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or castration-resistant prostate cancer (CRPC). Determination of progression is done per local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3).
• Serum testosterone levels <= 50 ng/dL (<= 1.73 nmol/L) within the screening period and prior to the first dose of the study drug.
• Must have received at least one NHA (e.g., enzalutamide and/or abiraterone). Additionally, participants must have received at least one taxane for prostate cancer (or have refused, or are intolerant to, or unable to get access to taxanes).
• Must have >= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <= 28 days prior to beginning study therapy.
• Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.
• Availability of representative baseline tumor tissue (most recent archived tumor tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane Antigen (PSMA) targeted therapy or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator.
• Laboratory values meeting the criteria laid out in the protocol.
• QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's correction), no >= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.

Exclusion Criteria:

• Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
• History of other active malignancy, as laid out in the protocol.
• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan.
• History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
• History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.

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Condition: Metastatic Castration-resistant Prostate Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05011188

Sponsor: Rahul Aggarwal

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Histologically confirmed metastatic prostate adenocarcinoma.
2. Disease progression by PCWG3 criteria at study entry.
3. Prior progression by PCWG3 criteria on one or more androgen signaling inhibitors including abiraterone acetate, enzalutamide, apalutamide, and/or darolutamide.
4. No prior taxane-based chemotherapy for the treatment of mCRPC. Prior taxane use in the castration-sensitive prostate cancer (CSPC) setting allowed provided last dose > 6 months prior to study entry.
5. Patients must be evaluable for the primary endpoint of composite response, and must have either serum PSA ≥ 2 ng/mL during Screening and/or measurable disease by RECIST 1.1 criteria.
6. Participants must be willing to undergo metastatic tumor biopsy during Screening. If there is no safely accessible metastatic lesion, this requirement will be waived.
7. Dose Expansion only: Participants must be willing to undergo CD46-directed Positron Emission Tomography (PET) imaging during Screening (Co-enrolling on NCT05245006, Groups B and C)
8. Castrate level of serum testosterone at study entry (<50 ng/dL). Patients without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study.
9. No other systemic anti-cancer therapies administered other than LHRH analogue within 14 days or, 5 half-lives, whichever is shorter, prior to initiation of study treatment. Adverse events related to prior anti-cancer treatment related to therapies other than LHRH analogue must have recovered to Grade ≤ 1 with the exception of any grade alopecia. a. Patients receiving enzalutamide prior to study entry may continue treatment at their current enzalutamide dose level without requirement for wash-out period.
10. Age >=18 years.
11. Eastern Cooperative Oncology Group (ECOG) performance status <= 1 (Karnofsky performance status >= 70 percent (%)).
12. Demonstrates adequate organ function as defined below:
13. Absolute neutrophil count ≥ 1,500/microliter (mcL).
14. Platelets >= 100,000/mcL and no platelet transfusions during the 14 days prior to first dose of FOR
15. Hemoglobin >= 8.0 grams per deciliter (g/dL) without red blood cell transfusion during the 14 days prior to first dose of FOR
16. Total bilirubin <=1.5 x institutional upper limit of normal (ULN), unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
17. Aspartate aminotransferase (AST) /serum glutamic-oxaloacetic transaminase (SGOT) <=3 x institutional institutional upper limit of normal (ULN).
18. Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) =3 x ULN.
19. Serum creatinine <= 1.5 x institutional upper limit of normal OR Calculated creatinine clearance glomerular filtration rate (GFR) >= 60 mL/min, calculated using the Cockcroft-Gault equation.
20. Serum sodium level >=130 mmol/L.
21. Ability to understand a written informed consent document, and the willingness to sign it.
22. Individuals with concurrent second malignancy requiring active treatment at study entry. Nonmelanoma skin cancer, non-muscle invasive bladder cancer, and other carcinomas-in-situ are allowable exceptions.
23. Patients must agree to use adequate contraception prior to the study, for the duration of study participation, and 60 days after last administration of study treatment. Adequate contraception includes:
24. Patients who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea > 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential.
25. Acceptable methods of contraception include continuous total abstinence, or double-barrier method of birth control (e.g. condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

1. Has received prior radiotherapy within 2 weeks of first dose of FOR
2. Prior treatment with FOR46 or another CD46-targeting therapeutic agent.
3. Prior histologic evidence of de novo or treatment-emergent small cell neuroendocrine prostate cancer. Pathologic assessment of baseline tumor biopsy performed during Screening is not required for determination of study eligibility.
4. Cardiac condition as defined as one or more of the following:
5. Uncontrolled supraventricular arrhythmia or ventricular arrhythmia requiring treatment.
6. New York Heart Association (NYHA) congestive heart failure class III or IV.
7. History of unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to Cycle 1, Day
8. History of seizure or pre-disposing condition including:
9. History of brain metastasis.
10. Cerebrovascular accident (CVA) within 6 months prior to study entry.
11. History of intracranial hemorrhage.
12. History of pneumonitis.
13. Is receiving systemic steroid therapy at a prednisone equivalent dose of > 10 milligram daily or other form of immunosuppressive therapy within 7 days prior to first dose of study drug.
14. Has an active infection requiring intravenous antibiotics within 7 days prior to Cycle 1, Day
15. Use of a prohibited concomitant medication within 7 days of first dose of FOR46, including: a. Strong inhibitor of CYP3A4 (boceprevir, clarithromycin, cobicistat, conivaptan, diltiazem, danoprevir/ritonavir, elvitegravir/ritonavir, grapefruit juice, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir/ombitasvir and/or dasabuvir, posaconazole, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin, and voriconazole).
16. Major surgery within 28 days prior to Cycle 1, Day
17. Minor procedures including biopsies, dental surgery, cataract surgery, or outpatient procedure are allowed.
18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

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Condition: Prostate Cancer, Prostate Adenocarcinoma, Biochemical Recurrence of Malignant Neoplasm of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06235099

Sponsor: Curium US LLC

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Patients with histologically proven prostate adenocarcinoma.
• Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.
• Recurrence of disease defined as: 1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or 2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.
• Male aged greater than or equal to 18 years.
• Able to understand and provide signed written informed consent.

Exclusion Criteria:

• Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.
• Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
• Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET scan) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
• Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
• Patients who are administered any high-energy (greater than 300 keV) gamma-emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration.
• Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
• Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.

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Condition: Prostate Adenocarcinoma, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03933670

Sponsor: University of California, San Francisco

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
• For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
• The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Absolute neutrophil count (ANC) >= 1000 cells/microliter (uL).
• Hemoglobin >= 9.0 gm/deciliter (dL).
• Platelets >= 75,000 cells/uL.
• Estimated creatinine clearance* >= 50 milliliter (mL)/min by the Cockcroft Gault equation.
• Total bilirubin =< 1.5 x upper limit of normal (ULN) or if =< 3 x ULN if known/suspected Gilbert's
• Aspartate aminotransferase (AST) =< 1.5 x ULN.
• Alanine aminotransferase (ALT) =< 1.5 x ULN.

Exclusion Criteria:

• Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
• Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
• Prior radiation treatment of the prostate.
• Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
• Poorly controlled hypertension, with blood pressure at study entry > 160 mm Hg systolic or > 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
• Congestive heart failure with New York Heart Association (NYHA) status >= 2.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03976843

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.
• Must have prostate cancer with high risk features defined as:
• Gleason 8 and higher OR
• PSA > 20 ng/mL OR
• Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
• Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
• Men age greater than or equal to 18 years.
• ECOG performance status <2
• Patients must have adequate organ and marrow function as defined below:
• Hemoglobin greater than or equal to 9 g/dL
• leukocytes greater than or equal to 3,000/mcL
• platelets greater than or equal to 100,000/mcL
• total bilirubin <2 X normal institutional limits
• AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
• creatinine <2 X normal institutional limits OR eGFR greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.
• Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT

Exclusion Criteria:

• Any investigational agents in the past 28 days prior to enrollment.
• Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).
• Distant metastatic disease on conventional imaging studies (computed tomography (CT)) of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed.
• Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry.
• Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.
• Contraindication to MRI or PET:
• Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry
• Prior reaction to 18F-DCFPyL
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T
• Severe claustrophobia unresponsive to oral anxiolytics
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy.
• A malignancy within the past 3 years for which prostatectomy is a contraindication.
• Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging.
• PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium.
• Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection.

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Condition: Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04134260

Sponsor: NRG Oncology

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
• Any T-stage is eligible (American Joint Committee on Cancer [AJCC] 8th edition [ed])
• Appropriate stage for study entry based on fluciclovine F-18 positron emission tomography (PET) scan (FACBC, Axumin) within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease; Note that though every effort should be made to obtain a fluciclovine F-18 PET (FACBC, Axumin) scan; however, if the patient has already had a recent F-18 PSMA PET (PyLarify) scan or gallium Ga 68-labeled PSMA-11 (Ga-68 PSMA) PET scan or C-11 or F-18 choline PET scan within 90 days prior to registration (to include scan report) then repeat molecular imaging with a fluciclovine F-18 PET (FACBC, Axumin) scan will not be required.
• Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (including external iliacs, internal iliacs, and/or obturator nodes); peri-prostatic and peri-rectal nodes can also be considered regional lymphadenopathy and are allowed
• History/physical examination within 90 days prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration
• Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA > 0 ng/mL at least 30 days after prostatectomy and within 180 days of registration and before start of GnRH agonist/antagonist
• Patients who have already started on post-prostatectomy GnRH agonist/antagonist for =< 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started =< 180 days and stopped prior to registration)
• Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration)
• Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration)
• Serum potassium >= 3.5 mmol/L within 90 days prior to registration
• Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault (please use actual weight for calculation unless greater than 30% above ideal body weight then use the adjusted body weight) (within 90 days prior to registration)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) (within 90 days prior to registration)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 90 days prior to registration)
• Serum albumin >= 3.0 g/dL (within 90 days prior to registration)
• Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to registration
• The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note: HIV testing is not required for eligibility for this protocol
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
• 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 within 30 days prior to registration
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ) who has no evidence of disease for < 3 years must contact the principal investigator, Ronald Chen, Doctor of Medicine (MD)
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria:

• Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11)
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Androgen deprivation therapy (ADT) prior to radical prostatectomy
• Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =< 180 days and stopped prior to registration, which is allowed
• Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
• History of any of the following:
• Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)
• Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration
• New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification.)
• History of any condition that in the opinion of the investigator, would preclude participation in this study
• Current evidence of any of the following:
• Known gastrointestinal disorder affecting absorption of oral medications
• Active uncontrolled infection
• Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment
• Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
• Baseline moderate and severe hepatic impairment (Child-Pugh Class B & C)
• Inability to swallow oral pills
• Any current condition that in the opinion of the investigator, would preclude participation in this study
• Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study
• Patients with inflammatory bowel disease

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Condition: Prostate Cancer, Advanced Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04346225

Sponsor: Ivan de Kouchkovsky, MD

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Histologically-confirmed locally advanced or metastatic prostate cancer. Patients with unequivocal clinical evidence supporting diagnosis of prostate cancer who have not had prior biopsy may be considered eligible per judgment of Principal Investigator.
2. Presence of at least one target lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:
3. Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI.
4. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify).
5. For patients with target lesion in prostate/prostatic bed: i. No contra-indications to endorectal coil insertion (e.g., patients with a prior abdominoperineal resection of the rectum or latex allergy). ii. No prior local treatment to the selected lesion, or evidence of radiographic progression following prior local therapy to selected lesion.
6. Able and willing to comply with study procedures and provide signed and dated informed consent.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
8. For patients undergoing optional tumor biopsy:
9. No history of bleeding diathesis.
10. Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.

Exclusion Criteria:

1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Patients unwilling or unable to undergo MR imaging, including patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
3. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI.
4. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures

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Condition: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05245006

Sponsor: Robert Flavell, MD, PhD

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC).
2. Age >=18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky >60%).
4. Demonstrates adequate organ function as defined below:
5. Total bilirubin <1.5 X upper limit of normal (ULN).
6. Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) <= 3 X institutional upper limit of normal (ULN).
7. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) <= 3 X institutional ULN.
8. Serum creatinine <=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) >= 60 mL/min, calculated using the Cockcroft-Gault equation.
9. Ability to understand a written informed consent document, and the willingness to sign it.
10. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Exclusion Criteria:

1. Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
3. Patients who have received the same antibody (YS5) earlier as part of therapy or detection.

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Condition: Prostate Cancer, Advanced Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05396872

Sponsor: University of California, San Francisco

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Patient-participants: 1. Age 18 years or older. 2. Able to understand study procedures and to comply with them for the entire length of the study. 3. Able to understand a written informed consent document and willing to sign it. 4. Able to speak, read, and understand English. 5. Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report. 6. Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing, somatic tumor testing, or targeted therapy. Caregiver-participants: 1. Age 18 years or older. 2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews. 3. Able to provide verbal consent. 4. Able to speak and understand English. Provider-participants: 1. Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed). 2. Has discussed germline testing, somatic testing, or targeted therapy for an San Francisco Veteran Health Care System (SFVAHCS) patient with locally advanced or metastatic prostate cancer (as defined above) within the past 90 days of being contacted about the study. 3. Able to provide consent via email. Stage 2: Inclusion Criteria: Patient participants: 1. Participated in Stage 1. 2. Completed either germline or tumor testing for prostate cancer. 3. Able to understand study procedures and to comply with them for the entire length of the study. Caregiver-participants: 1. Participated in Stage 1. 2. Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver). SFVAHCS Provider-participants: 1. Participated in Stage 1. 2. Meets one of the two following criteria:
• Physician specializing in medical oncology (MD, post-first year clinical fellows allowed) who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
• Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study. Non-SFVAHCS provider-participants: 1. Meets one of the three following criteria:
• Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.
• Physician specializing in medical oncology who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
• Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study. Note: For Non-SFVAHCS providers, fellows are not eligible. 2. Able to understand study procedures and to comply with them for the entire length of the study. Stage 3: Inclusion Criteria Patient-participants 1. Age 18 years or older. 2. Able to understand study procedures and to comply with them for the entire length of the study. 3. Able to understand a written informed consent document and willing to sign it. 4. Able to speak, read, and understand English. 5. Documentation of high-risk localized, very high-risk localized, locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report. 6. Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing. Caregiver-participants 1. Age 18 years or older. 2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interview. 3. Able to provide verbal consent. 4. Able to speak and understand English. Provider-participants 1. SFVAHCS physician (MD) trained in medical oncology or undergoing training as a clinical fellow. 2. Has discussed germline testing for prostate cancer with an SFVAHCS patient within the past year of being contacted about the study, or plans to discuss germline testing for prostate cancer with an SFVAHCS patient. 3. Able to provide verbal consent. Stage 1: Exclusion Criteria Patient-participants: 1. For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible. Caregiver and Provider-Participants 2. If they do not meet any of the inclusion criteria above. Stage 2: Exclusion Criteria 1. Participants who do not meet the inclusion criteria above. Stage 3

Exclusion Criteria:

1. Patient-participants:
2. For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible. Caregiver and Provider-Participants
3. If they do not meet any of the inclusion criteria above. Stage 2: Exclusion Criteria
4. Participants who do not meet the inclusion criteria above. Stage 3: Exclusion Criteria Patient-participants:
5. Prior receipt of germline testing.
6. Prior participation in Stage 1 for germline testing. Caregiver and Provider-Participants
7. If they do not meet any of the inclusion criteria above.

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Condition: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05519449

Sponsor: Janux Therapeutics

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum 100 Years
• Gender: Male

Inclusion Criteria:

• Male ≥18 years of age at the time of signing informed consent
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
• Adequate organ function

Exclusion Criteria:

• Prior solid organ transplant
• Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
• Clinically significant cardiovascular disease
• Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
• Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

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Condition: Prostate Cancer, Localized Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05851365

Sponsor: Robert Flavell, MD, PhD

Phase: Early Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Patients age >=18 years. 2. Patients must have biopsy-proven adenocarcinoma of the prostate; biopsy may be performed outside of University of California, San Francisco (UCSF) if detailed results of sextant biopsy are available. 3. Tumor size of at least 1.0 cm in long axis on Magnetic resonance imaging (MRI) or ultrasound; if no prior imaging is available, at least 3 cores positive on biopsy. 4. Patients must have planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/ magnetic resonance spectroscopy imaging) (MRSI). 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Demonstrates adequate organ function as defined below: 1. Adequate bone marrow function:
• Absolute neutrophil count >=1,500 cells/µL.
• Platelets >=75,000 cells/µL.
• Hemoglobin >=9.0 gm/dL. 2. Adequate hepatic function:
• Total bilirubin <1.5x upper limits of normal (ULN) (within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) <=1.5 X institutional upper limit of normal.
• Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <=1.5 X institutional upper limit of normal. 3. Adequate renal function:
• Creatinine clearance >= 50 calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2. 7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who because of general medical or psychiatric condition, or physiologic status, cannot give valid informed consent.
2. Patients unwilling or unable to undergo MR imaging, including patients with contraindications to Magnetic resonance imaging (MRI) as per UCSF radiology departmental guidelines.
3. Patients who cannot tolerate or have contra-indications to endorectal coil insertion, for example, patients with a prior abdominoperineal resection of the rectum or latex allergy.
4. Patients with contra-indications to injection of gadolinium contrast as per UCSF radiology departmental guidelines.
5. Patients who take carbonic anhydrase inhibitors (e.g. acetazolamide, dichlorphenamide, methazolamide).
6. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
7. Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. No limit on number of prior prostate biopsies. Prior Transurethral Resection of the Prostate (TURP) is not allowed.
8. Poorly controlled hypertension, with blood pressure at study entry >160/1
9. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
10. Congestive heart failure or New York Heart Association (NYHA) status >=
11. A history of clinically significant electrocardiogram (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter will be allowed on study.

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Condition: Castrate Resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05766371

Sponsor: University of California, San Francisco

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Histologically confirmed prostate adenocarcinoma that is progressive metastatic castration-resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria at the time of study entry. 2. Male participants who are at least 18 years of age on the day of signing informed consent. 3. Castrate level of serum testosterone at study entry (< 50 ng/dL). Note: Patients without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study. 4. Have received at least one prior line of taxane chemotherapy, or are unfit for, or refuse taxane chemotherapy. Note: Taxane chemotherapy administered in the Castration Sensitive Prostate Cancer (CSPC) or Castration Resistant Prostate Cancer (CRPC) setting is allowed. 5. Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide. 6. Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade <= 1 (except for any grade alopecia and grade <= 2 neuropathy). 7. Prior radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on cycle 1, day 1 (C1D1). Note- Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease. 8. At least one Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) (PSMA PET) avid lesion on screening PSMA PET. A positive lesion is defined as uptake above background liver. 9. Eastern Cooperative Oncology Group (ECOG) performance status <= 1 (Karnofsky >= 70%). 10. Demonstrates adequate organ function as defined below: 1. Adequate bone marrow function:
• absolute neutrophil count >=1,500/microliter (mcL)
• platelets >=100,000/mcL
• hemoglobin > 9.0 g/dL 2. Adequate hepatic function:
• total bilirubin <= 1.5 x upper limit of normal (ULN). In patients with known or suspected Gilbert's disease, direct bilirubin <= ULN
• aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) <= 2.5 x institutional ULN (<= 5 x ULN in patients with liver metastases)
• alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <= 2.5 x institutional upper limit of normal (<= 5 x ULN in patients with liver metastases) 3. Adequate renal function:
• creatinine <= 1.5 x within institutional upper limit of normal OR
• creatinine clearance Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2, calculated using the Cockcroft-Gault equation or 24 hour urine collection. 11. Patients must use appropriate methods of contraception during study treatment and for at least 6 months after last study treatment. Patients who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea > 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential. Patients who have undergone vasectomy themselves should also be considered to be of childbearing potential. Acceptable methods of contraception include continuous total abstinence, or double-barrier method of birth control (e.g., condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception. 12. Patients must provide consent to comply to recommended radioprotection precautions during study. 13. Patients willing to undergo tumor biopsy and have at least one lesion safely accessible to tumor biopsy. Bone or soft tissue lesion is allowed. 14. Patients with previously treated brain metastases are eligible provided the following criteria are all met: 1. Last treatment was > 28 days prior to C1D1. 2. No evidence of new/progressive brain metastases is observed on magnetic resonance imaging (MRI) obtained during screening window 3. Patient is clinically stable without requirement of steroid treatment for at least 14 days prior to first dose of study treatment on C1D1. 15. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 16. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype. Note-Treatment-emergent small cell neuroendocrine prostate cancer detected in metastatic tumor biopsy is not excluded.
2. Soft tissue lesions (lymph nodes > 1.5 centimeter (cm) in short axis, visceral/soft tissue lesions > 1 cm) on screening Computerized tomography (CT) that are negative on PSMA PET. Note: Negative lesions on PSMA PET are defined as those with uptake below the background liver.
3. Has received other systemic anti-cancer therapies administered within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception.
4. Untreated brain metastases at study entry.
5. Receipt of prior PSMA-directed treatment (e.g., radiotherapy, immunotherapy, or antibody-drug conjugate).
6. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-Programmed cell death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137).
7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D
8. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
9. Receipt of > 2 lines of prior taxane-based chemotherapy.
10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
11. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazole, carbimazole, etc.) that function to decrease the generation of thyroid hormone by a hyper-functioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.
12. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a prednisone equivalent dose of > 10 mg daily or other form of immunosuppressive therapy within 7 days prior to first dose of study drug.
13. Has a history of (non-infectious) ≥ grade 2 pneumonitis/interstitial lung disease that required steroids within past 2 years or has current ≥ grade 1 pneumonitis/ interstitial lung disease at the time of study enrollment.
14. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug on C1D
15. Note-Administration of a killed vaccine is allowed.
16. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
17. Has clinically significant cardiovascular disease including, but not limited to:
18. Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure.
19. Uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months before study entry.
20. Clinically significant arrhythmias not controlled by medication. Note: Chronic rate controlled or paroxysmal atrial fibrillation/flutter is not an exclusion to study participation.
21. Prior external beam radiation involving > 25 percent (%) of bone marrow or within 14 days of start of protocol therapy on C1D
22. Major surgery within 28 days of study treatment. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment on C1D
23. Minor procedures (e.g., biopsy, cataract surgery, stent placement, endoscopy) are not considered major surgery.
24. Has an active infection requiring intravenous antibiotics within 7 days prior to C1D
25. Has a known history of human immunodeficiency virus (HIV) infection. Note: Screening not required.
26. Has a known history of Hepatitis B infection (defined as Hepatitis B surface antigen (HBsAg) reactive) or known active Hepatitis C virus infection (defined as (HCV RNA) [qualitative] detected, with the following exceptions:
27. participants who are HbsAg positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study entry
28. participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to study entry.
29. Has a known history of active Bacillus Tuberculosis (TB).
30. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
31. History of bleeding diathesis and currently on anti-coagulation therapy that cannot be safely discontinued for the tumor biopsy procedure.
32. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.

View trial on ClinicalTrials.gov