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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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 Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Active drug

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

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.

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.

HealthScout AI summary: Adults with prostate adenocarcinoma: mainly metastatic castration-resistant disease post–AR-targeted therapy (some cohorts require prior taxane or prior 177Lu-PSMA), plus a metastatic hormone-sensitive cohort including oligometastatic patients eligible for SBRT. Investigational therapy is JNJ-69086420 (alpitatug), an Actinium-225–labeled anti–hK2 radioimmunotherapy; given as monotherapy at escalating/expansion doses, with a combination cohort adding JNJ-78278343 (pasritamig), a KLK2×CD3 bispecific T-cell engager.

ClinicalTrials.gov ID: NCT04644770

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.

HealthScout 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.

HealthScout 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

Efficacy of Ra-223 in PSMA PET Optimally Selected Patients

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.

HealthScout AI summary: Men with PSMA PET–positive, bone-predominant mCRPC (no visceral disease) after at least one AR pathway inhibitor and minimal prior taxane exposure receive radium-223 dichloride IV every 28 days for 6 cycles. Radium-223 is an alpha-emitting calcium mimetic targeting osteoblastic metastases to deliver localized high-LET radiation; primary outcome is PSA50 response, with secondary survival, skeletal event, imaging, and safety endpoints.

ClinicalTrials.gov ID: NCT05924672

A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Active drug

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

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.

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.

HealthScout AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma (ECOG 0–1) previously treated with at least one AR-targeted therapy or chemotherapy receive JNJ-78278343 (pasritamig), an IV KLK2xCD3 bispecific T‑cell–redirecting antibody given with step-up dosing then Q6W maintenance. Key exclusions include active CNS disease, significant autoimmune/infectious comorbidities, prior KLK2‑targeted therapy, and recent immunosuppression.

ClinicalTrials.gov ID: NCT04898634

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.

HealthScout 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