Clinical Trials for Prostate Cancer

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

A Phase 2 Umbrella Protocol of Enfortumab Vedotin as Monotherapy and Combined With Other Agents in Patients With Metastatic 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: For men with metastatic castration-resistant prostate adenocarcinoma after ≥1 novel hormonal therapy and prior taxane, ECOG 0–2, this study tests enfortumab vedotin given D1/8/15 q28d. Enfortumab vedotin is a Nectin‑4–targeted antibody–drug conjugate delivering MMAE; initial cohort is monotherapy with potential future combination cohorts.

ClinicalTrials.gov ID: NCT04754191

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

A Phase 2 Study of Cabozantinib and Nivolumab in 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 progressive metastatic castration-resistant prostate cancer after at least one taxane and one AR-targeted therapy (177Lu-PSMA-617 allowed; ECOG 0–2; excludes prior PD-1/PD-L1 progression or prior cabozantinib) receive cabozantinib 40 mg daily plus nivolumab 480 mg IV q4w. Cabozantinib is a multi-kinase inhibitor (MET/VEGFR2/AXL) with anti-angiogenic and bone microenvironment effects, combined with the PD-1 inhibitor nivolumab to potentially enhance immune response.

ClinicalTrials.gov ID: NCT05502315

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

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

A Phase 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

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: Biomarker-selected mCRPC (adenocarcinoma or small cell) after at least one AR pathway inhibitor, requiring dMMR/MSI-H or CDK12-altered tumors (NGS-defined), ECOG 0–1, and castrate testosterone. Single-arm pembrolizumab 200 mg IV q3w (anti–PD-1 immune checkpoint inhibitor) continued with ongoing ADT; excludes prior PD-1/PD-L1/CTLA-4 therapy and active autoimmune disease.

ClinicalTrials.gov ID: NCT04104893

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