Clinical Trials for Prostate Cancer

Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 metastatic castration-resistant prostate adenocarcinoma (progressed after ≥2 prior systemic regimens including a second‑generation AR‑targeted agent; PSA ≥4; progression within 6 months) receive the investigational PSMA×CD3 T‑cell–redirecting bispecific REGN4336 alone or combined with cemiplimab (anti–PD‑1) or REGN5678/nezastomig (PSMA×CD28 costimulatory bispecific), with step‑up dosing and optional IL‑6 blockade to mitigate CRS. Prior PSMA radioligand therapy is allowed; PSMA‑targeted non‑radioligand therapies are excluded.

ClinicalTrials.gov ID: NCT05125016

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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 newly diagnosed metastatic hormone‑naive prostate adenocarcinoma within 42 days of starting ADT receive abiraterone acetate plus low‑dose prednisone until progression, with PSA response and outcomes correlated with race/ethnicity, baseline PSA decline, and germline variants in androgen metabolism pathways. Excludes prior chemo for metastatic disease and significant cardiac comorbidity; aims to enroll a racially diverse cohort (about half African American).

ClinicalTrials.gov ID: NCT03833921

Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) 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.

TrialFetch AI summary: Asymptomatic men with mCRPC progressing after abiraterone (ECOG 0–2) receive sequential cycles of DFMO (eflornithine; irreversible ornithine decarboxylase inhibitor targeting polyamine synthesis) with high‑dose testosterone (BAT) followed by enzalutamide, while continuing castration. Prior AR-targeted agents, taxanes, PARP inhibitors, radiopharmaceuticals, and prior BAT are allowed; key exclusions include opioid-requiring pain, high-flare risk sites, significant hearing loss, and seizure risk.

ClinicalTrials.gov ID: NCT06059118

Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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.

TrialFetch AI summary: Adults with mCRPC progressing on continuous androgen suppression after at least one AR signaling inhibitor and one chemotherapy, with measurable and biopsiable disease, receive bipolar androgen therapy: intramuscular testosterone cypionate every 28 days for 3 cycles while maintaining medical castration with leuprolide. The approach cycles testosterone from castrate to supraphysiologic levels to modulate androgen receptor signaling and potentially re-sensitize tumors, with assessments of AR activity, PSA response, and safety.

ClinicalTrials.gov ID: NCT06305598

Vorinostat to Augment Response to 177Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low 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.

TrialFetch AI summary: Adults with PSMA-low mCRPC after at least one ARSI and one taxane receive a 28-day lead-in of vorinostat (HDAC inhibitor intended to upregulate PSMA) with PET reassessment, followed by standard 177Lu-PSMA-617 radioligand therapy for eligible converters. Aims to determine conversion to PSMA-high and subsequent antitumor activity and safety of the combination.

ClinicalTrials.gov ID: NCT06145633

A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

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.

TrialFetch AI summary: Adults with mCRPC after prior docetaxel (no prior cabazitaxel/carboplatin), adequate organ function, and available tissue for central AVPC molecular-pathologic signature (TP53/RB1/PTEN by IHC) are randomized to cabazitaxel plus prednisone with or without carboplatin. The study tests whether adding carboplatin (DNA crosslinking platinum) to cabazitaxel (microtubule inhibitor) improves rPFS, with primary focus on AVPC-MS–positive disease.

ClinicalTrials.gov ID: NCT06470243

Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate 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.

TrialFetch AI summary: Adults with PSMA-positive metastatic castration-resistant prostate cancer at Mayo Clinic Rochester who achieve a near-complete response on post-therapy SPECT after initial 177Lu-PSMA-617 are randomized to continue standard 177Lu-PSMA-617, pause after 5 cycles with retreatment at progression, or initial observation with deferred 177Lu-PSMA-617 at first progression. 177Lu-PSMA-617 is a PSMA-targeted radioligand therapy delivering beta radiation to PSMA-expressing cells; the trial tests whether imaging-guided de-escalation maintains disease control while reducing exposure.

ClinicalTrials.gov ID: NCT06200103

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

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.

TrialFetch AI summary: Men with metastatic castration-sensitive prostate adenocarcinoma starting or on first-line intensified ADT (abiraterone, apalutamide, enzalutamide, or darolutamide; with or without prior chemotherapy) are randomized to monthly 5-day fasting-mimicking diet vs standard diet added to standard-of-care. Evaluates impact on PSA response and metabolic outcomes; excludes underweight patients, unstable diabetes, significant comorbidities, recent major weight loss, or regular fasters.

ClinicalTrials.gov ID: NCT05832086

A Single Arm Open-label, Phase II Study of Sipuleucel-T with Bipolar Androgen Therapy in Men 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.

TrialFetch AI summary: Men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (ECOG 0–1, castrate testosterone) receive bipolar androgen therapy with intramuscular testosterone cypionate plus standard sipuleucel-T. Sipuleucel-T is an autologous APC-based vaccine activated ex vivo with PA2024 (PAP–GM-CSF) and BAT provides cyclical supraphysiologic testosterone to stress tumor cells; the study targets immunologic enhancement and assesses PSA/radiographic outcomes.

ClinicalTrials.gov ID: NCT06100705

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

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.

TrialFetch AI summary: Men with asymptomatic or minimally symptomatic metastatic castrate‑resistant prostate cancer who have completed the standard three infusions of sipuleucel‑T (PROVENGE) are randomized to receive a single booster sipuleucel‑T infusion at 6–9 months versus no booster. Sipuleucel‑T is an autologous cellular immunotherapy activating APCs with a PAP–GM‑CSF fusion protein (PA2024); the study assesses boosted immune responses and clinical outcomes, including overall survival.

ClinicalTrials.gov ID: NCT06134232