Clinical Trials for Prostate Cancer

A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Men with previously treated, hormone-sensitive oligometastatic prostate adenocarcinoma (1–5 PSMA-PET–avid lesions amenable to SBRT) receive fractionated 177Lu-PSMA-617 followed by SBRT (9 Gy × 3) to all sites. 177Lu-PSMA-617 is a PSMA-targeted beta-emitting radioligand delivering lutetium-177 to PSMA-expressing cells; the study evaluates safety/feasibility of this combination in the HSPC, oligometastatic setting.

ClinicalTrials.gov ID: NCT05079698

Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I/II Trial

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced solid tumors lacking options (phase I) and an expansion in relapsed/advanced prostate cancer (phase II), ECOG 0–2, receive an oral combination targeting autophagy and growth-survival pathways: hydroxychloroquine (lysosomal/autophagy inhibitor), sirolimus (mTORC1 inhibitor), metformin (AMPK activation/indirect mTOR suppression), with stepwise addition of dasatinib (Src/Abl inhibitor) and/or nelfinavir (HIV protease inhibitor causing ER stress/PI3K–AKT inhibition). Phase II focuses on 16-week disease control in prostate cancer at the RP2D.

ClinicalTrials.gov ID: NCT05036226

High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling men with metastatic castration-resistant prostate cancer who have inactivating mutations in ATM, CDK12, or CHEK2 after prior next-generation AR-signaling inhibitor, asymptomatic/minimally symptomatic, ECOG 0–1. Patients receive bipolar androgen therapy (intermittent high-dose testosterone while maintaining castration) to exploit DNA damage/replication stress and AR signaling disruption, hypothesized to be particularly active in DDR-deficient tumors.

ClinicalTrials.gov ID: NCT05011383

A Phase I/II Study to Determine the Safety and Efficacy of a Combination of Green Tea and Quercetin With Docetaxel in Castration-resistant Prostate Cancer Patients

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Men with metastatic castration-resistant prostate cancer progressing on continuous ADT and prior AR pathway inhibitors, eligible to start docetaxel/prednisone, are randomized to docetaxel/prednisone plus green tea extract and quercetin versus placebo. The investigational add-on comprises dietary polyphenols (EGCG-rich green tea extract and quercetin) with proposed chemosensitizing/anti-tumor activity via signaling, oxidative stress, and drug transport/metabolism modulation; the study evaluates PSA response, radiographic outcomes, safety, and pharmacokinetics.

ClinicalTrials.gov ID: NCT06615752

A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Metastatic castration-resistant prostate cancer progressing on prior taxane therapy (docetaxel or cabazitaxel); ECOG 0–2. Adds high-dose omeprazole (repurposed fatty acid synthase inhibitor) to ongoing cabazitaxel or docetaxel to assess radiographic response, PSA/pain outcomes, and pharmacodynamic target engagement.

ClinicalTrials.gov ID: NCT04337580

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Veterans with oligometastatic or oligo-recurrent prostate cancer (1–10 PSMA/fluciclovine/choline PET-detected lesions; ECOG ≤2) are randomized to standard systemic therapy (ADT ± first-generation antiandrogen; optional intensification with docetaxel, abiraterone, apalutamide, or enzalutamide; de novo cases also get prostate RT) with or without PET-directed local therapy to all sites (SBRT/surgery and salvage local therapy when feasible). No investigational drugs; compares addition of metastasis-directed therapy to contemporary systemic care.

ClinicalTrials.gov ID: NCT04787744

A Phase 2 Study of Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Metastatic Castration Resistant Prostate Cancer

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Men with mCRPC after ≥1 second-generation ARSI (± up to two taxane lines), PSMA-PET–avid disease, and ECOG 0–1 receive pembrolizumab (PD‑1 inhibitor) plus 177Lu‑PSMA‑617 radioligand therapy, with two initial Lu‑PSMA doses then adaptive re-dosing at PSA rise until progression/toxicity. Excludes prior PSMA-directed therapy or checkpoint inhibitors; allows treated/stable brain metastases.

ClinicalTrials.gov ID: NCT05766371

Phase 1/2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma after ≥2 prior lines (including a next-generation AR inhibitor) and castrate testosterone receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous STEAP1-directed CAR T cells plus continuous enzalutamide. The investigational product is a CAR T therapy targeting STEAP1 to direct T‑cell cytotoxicity against STEAP1-expressing tumors; key exclusions include active autoimmune disease requiring immunosuppression, uncontrolled infection, and untreated/symptomatic brain metastases.

ClinicalTrials.gov ID: NCT06236139

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors refractory to standard therapy (mCRPC, metastatic breast cancer subtypes including TNBC, HR+/HER2− or HER2-low, HR−/HER2+, NSCLC, CRC, PDAC) receive MBRC-201, an investigational antibody‑drug conjugate targeting a tumor-associated antigen and delivering a likely topoisomerase I inhibitor payload. Requires ECOG 0–2 and measurable disease in expansion/Phase 2; excludes active CNS disease and prior camptothecin‑payload ADCs in later phases.

ClinicalTrials.gov ID: NCT07145255

177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with PSMA-avid metastatic castration-resistant prostate adenocarcinoma and bone marrow involvement causing baseline anemia (Hgb 7 to <9 g/dL or recent pretransfusion <8) and/or thrombocytopenia (platelets 50–100 × 10^9/L), with PSA progression after at least one prior approved systemic therapy (while continuing ADT) and ECOG 0–2. All patients receive 177Lu-PSMA-617, a PSMA-targeted radioligand delivering lutetium-177 beta radiation to PSMA-expressing tumor cells, with primary focus on hematologic safety/tolerability in this cytopenic population.

ClinicalTrials.gov ID: NCT07025512