Clinical Trials for Prostate Cancer

A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ 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: Adults with PSCA-expressing metastatic castration-resistant prostate cancer after at least one next-generation AR pathway inhibitor receive lymphodepleting chemotherapy followed by autologous PSCA-directed CAR T cells (4-1BB/CD3ζ with CD19t tag), with an optional cohort adding metastasis-directed radiation (16 Gy in 2 fractions) before lymphodepletion. Key aims are safety/feasibility and preliminary activity, with allowance for up to three CAR T infusions per course.

ClinicalTrials.gov ID: NCT05805371

A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic 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: Asymptomatic men with mCRPC progressing on abiraterone plus ongoing ADT (testosterone <50 ng/dL), ECOG 0–2, and no prior AR antagonists or CRPC chemotherapy are randomized to continuous enzalutamide vs alternating cycles of supraphysiologic testosterone cypionate (bipolar androgen therapy; induces AR feedback disruption/DNA damage with potential AR re-sensitization) and enzalutamide, including a PSA-driven switching arm. Continues until clinical or radiographic progression; excludes patients with cancer-related pain, high thromboembolic risk, or conditions that increase risk from testosterone.

ClinicalTrials.gov ID: NCT04363164

A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)

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-PET–positive mCRPC after at least one ARSI and one chemotherapy (ECOG 0–2) are randomized to 177Lu-PSMA-617 (vipivotide tetraxetan), a PSMA-targeted radioligand delivering lutetium-177 beta radiation, given either on a response-adapted flexible schedule with possible holidays and up to 12 cycles vs the standard six cycles every six weeks. Key exclusions include prior 177Lu-PSMA-617 and significant urinary obstruction/hydronephrosis.

ClinicalTrials.gov ID: NCT06216249

Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease

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 biopsy-proven local recurrence of prostate cancer after prior definitive radiation (± limited metastases), good performance status, IPSS <15, and prostate volume <50 cc receive salvage prostate brachytherapy combined with intraprostatic adenoviral HSV‑tk gene therapy plus short-course oral valacyclovir. The investigational HSV‑tk/valacyclovir suicide gene therapy targets HSV‑tk–expressing tumor cells to activate nucleoside analog cytotoxicity with potential bystander/immune effects; symptomatic metastatic disease and significant immunosuppression are excluded.

ClinicalTrials.gov ID: NCT01913106

AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease

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 characterized by non-measurable disease (often bone-predominant) after at least one novel hormonal agent, ECOG 0–2, and no prior PD-(L)1, CTLA-4, cabozantinib, or mCRPC chemotherapy. Patients receive cabozantinib (multi-kinase TKI targeting MET/VEGFR2/AXL) daily plus atezolizumab (anti–PD-L1) IV every 21 days until progression/toxicity.

ClinicalTrials.gov ID: NCT05168618

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in De Novo OligometaStatic Prostate Cancer (TERPS) 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: Men with de novo oligometastatic, hormone-sensitive prostate cancer (ECOG 0–2; 1–3 mets on conventional imaging with ≥1 bone, or up to 5 on PET) receive standard systemic therapy plus definitive prostate radiotherapy, randomized to add stereotactic ablative radiotherapy (SABR) to all metastatic sites versus no SABR. Prior short-course ADT/systemic therapy allowed; key exclusions include castration-resistant disease and bulky visceral metastases.

ClinicalTrials.gov ID: NCT05223803

Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study

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 castration-sensitive biochemical recurrence after prostatectomy and prior adjuvant/salvage RT, negative on conventional imaging but with PSMA or fluciclovine PET/CT stratification, receive either surveillance (PET confined to fossa), metastasis-directed therapy to ≤3 lesions plus abiraterone/prednisone, or abiraterone/prednisone alone (>3 regions). Abiraterone is a CYP17A1 inhibitor that suppresses androgen biosynthesis; outcomes include undetectable PSA at 2 years and time to systemic therapy.

ClinicalTrials.gov ID: NCT04175431

Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced 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 locally advanced or metastatic prostate cancer (ECOG 0–1) with at least one MRI/CT-visible lesion receive intravenous hyperpolarized 13C-pyruvate followed by metabolic MR spectroscopic imaging to quantify pyruvate-to-lactate (glycolysis via LDH) and pyruvate-to-glutamate (TCA-linked) flux. Imaging is performed once or serially to assess intratumoral heterogeneity and early metabolic response to ongoing systemic therapy; no therapeutic intervention is assigned.

ClinicalTrials.gov ID: NCT04346225

An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.

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 progressive PSMA-positive mCRPC (ECOG 0–2) stratified by renal function (normal, moderate, severe impairment) receive lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617), a PSMA-targeted beta-emitting radioligand therapy, to assess biodistribution, dosimetry, PK, urinary excretion, and safety; dosing is 7.4 GBq q6 weeks (6 cycles for normal/moderate; 3 with possible extension in severe impairment). Excludes prior PSMA RLT and significant QT risk/medications during Cycle 1; all require PSMA-avid disease on 68Ga-PSMA-11 PET/CT.

ClinicalTrials.gov ID: NCT06004661

Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in 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 progressive metastatic castration-resistant prostate cancer on ADT who had a poor response to prior abiraterone (e.g., short duration or no PSA50), ECOG 0–2, and no prior chemotherapy for mCRPC receive ruxolitinib (JAK1/2 inhibitor targeting JAK-STAT/inflammatory stem-like pathways) plus enzalutamide. Single-arm dose-escalation/expansion assesses safety and preliminary efficacy (PSA50, RECIST responses, PFS); key exclusions include untreated brain mets, recent major CV/thromboembolic events, active hepatitis/TB, and seizure history.

ClinicalTrials.gov ID: NCT06616155