Clinical Trials for Prostate Cancer

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

A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate

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: Enrolling adults with mCRPC harboring pathogenic HRR mutations (e.g., BRCA1/2, ATM [≤15%], CDK12, CHEK2, PALB2, etc.) after progression on abiraterone, castrate testosterone, and ECOG 0–1; excludes prior PARP inhibitors/platinum and prior ARPI for CRPC other than abiraterone. Randomizes to talazoparib (PARP1/2 inhibitor) plus enzalutamide (androgen receptor inhibitor) versus talazoparib alone.

ClinicalTrials.gov ID: NCT06844383

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

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 de novo or metachronous high-volume metastatic castration-sensitive prostate adenocarcinoma (M1 on conventional imaging; no PSMA-PET–only or N1-only disease) are randomized to ADT plus apalutamide versus ADT plus apalutamide with docetaxel (up to 6 cycles). Apalutamide is a second‑generation androgen receptor antagonist; docetaxel is a microtubule-stabilizing taxane, and the trial tests whether adding docetaxel to the ADT+apalutamide backbone improves overall survival, including in genomically defined subgroups (TP53/PTEN/RB1).

ClinicalTrials.gov ID: NCT06931340

A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)

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 metastatic hormone-sensitive prostate adenocarcinoma who achieve a deep PSA response (≤0.2 ng/mL) receive relugolix (oral GnRH receptor antagonist) plus an ARPI (abiraterone, enzalutamide, apalutamide, or darolutamide), with randomization to intermittent versus continuous therapy in newly treated patients and a single-arm intermittent strategy for those already suppressed. Aims to reduce fatigue and preserve disease control while characterizing outcomes and quality of life with intermittent ADT/ARPI.

ClinicalTrials.gov ID: NCT07216248

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA 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 metastatic castration-sensitive prostate adenocarcinoma on ADT for 6–12 months plus an AR pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide) for ≥4 months who have castrate testosterone but suboptimal PSA response (PSA ≥0.2 ng/mL) and no radiographic/clinical progression are randomized to continue ADT+ARPI versus add docetaxel IV chemotherapy (a taxane microtubule stabilizer that also disrupts androgen receptor trafficking/signaling). Key exclusions include prior taxane therapy, early castration-resistant PSA rise pattern, and significant neuropathy or hypersensitivity to polysorbate 80 formulations.

ClinicalTrials.gov ID: NCT06592924