Clinical Trials for Prostate Cancer

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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 cancer, including adenocarcinoma and treatment-emergent or de novo neuroendocrine variants, receive pembrolizumab-based combinations tailored by cohort after prior AR-targeted therapy and/or chemotherapy per rules. Regimens include pembrolizumab with olaparib (PARP inhibitor), docetaxel/prednisone, enzalutamide, abiraterone/prednisone, lenvatinib (VEGFR/FGF/MET/RET inhibitor), vibostolimab (anti-TIGIT) coformulated with pembrolizumab, platinum–etoposide with or without pembrolizumab for NEPC, and belzutifan (HIF-2α inhibitor) alone or with pembrolizumab.

ClinicalTrials.gov ID: NCT02861573

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression

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 PSMA-expressing tumors, primarily mCRPC post–ARPI (and including a post–177Lu‑PSMA‑617 cohort) and previously treated metastatic ccRCC, receive REGN5678 (nezastomig), a PSMA×CD28 costimulatory bispecific antibody, as monotherapy or with the PD‑1 inhibitor cemiplimab. Aims include identifying active/safe doses and assessing responses, with combination use tempered by prior immune‑related toxicities.

ClinicalTrials.gov ID: NCT03972657

Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy

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 biochemically recurrent or oligometastatic (≤5 sites) prostate adenocarcinoma after radical prostatectomy (PSA 0.1–<2.0 ng/mL, ECOG 0–2) are randomized to salvage SBRT (5 fractions over 1–2 weeks) versus moderately hypofractionated RT (20 fractions over 4–6 weeks), with optional ADT up to 18 months. The study compares toxicity and disease control between these two standard radiation approaches.

ClinicalTrials.gov ID: NCT06205316

Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA 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.

TrialFetch AI summary: Single-arm re-challenge of PSMA-positive mCRPC patients who previously had a ≥50% PSA decline after ≥4 cycles of 177Lu-PSMA-617 and have since progressed, all post-ARSI and taxane therapy with adequate organ function. Patients receive IV 177Lu-PSMA-617 (PSMA-targeted beta-emitting radioligand) every 6 weeks for up to 6 cycles; endpoints include OS, PSA/radiographic responses, and safety.

ClinicalTrials.gov ID: NCT06288113

Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced 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: Enrolling adult men with advanced prostate cancer across disease states, including mCRPC (expansion cohorts require prior abiraterone or exactly one prior ARPI), with ECOG 0–1 and adequate organ function. Investigational treatment is intramuscular PRL-02 (abiraterone decanoate), a long-acting CYP17 inhibitor depot given every 12 weeks with prednisone or dexamethasone, with or without enzalutamide depending on cohort.

ClinicalTrials.gov ID: NCT04729114

A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN 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: Men with hormone-sensitive oligorecurrent prostate adenocarcinoma confined below the diaphragm (≤5 PSMA PET/CT–positive lesions with at least one para-aortic node, no bone/visceral mets) after prior pelvic RT receive PSMA-PET–directed para-aortic radiation (photon or proton) plus up to 6 months of ADT and an androgen receptor signaling inhibitor. Aims to improve disease control and delay escalation, with PFS and patient-reported outcomes tracked.

ClinicalTrials.gov ID: NCT06392295

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic 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: Enrolls adults with metastatic prostate adenocarcinoma (mainly mCRPC after prior ARPI ± docetaxel; one cohort includes mHSPC with non-castrate testosterone and bone-only disease) to receive the KLK2×CD3 bispecific T‑cell engager pasritamig (JNJ‑78278343) combined with either cetrelimab (PD‑1 inhibitor), a taxane (docetaxel or cabazitaxel), or an ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone/prednisone). Open-label cohorts assess safety and preliminary activity to define recommended regimens; ECOG 0–1 and measurable/evaluable disease required.

ClinicalTrials.gov ID: NCT05818683

A Phase II Study of Bortezomib in Patients with Metastatic Castration-Resistant Prostate Cancer with PTEN Deletion

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: Biomarker-selected mCRPC patients with PTEN deletion after at least one AR pathway inhibitor and no prior chemotherapy for mCRPC receive single-agent bortezomib (1.3 mg/m2 SC days 1, 4, 8, 11 every 21 days). Bortezomib is a reversible 26S proteasome inhibitor that may exploit PI3K/AKT pathway dysregulation in PTEN-loss tumors; key exclusions include ≥grade 2 neuropathy and uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT06029998

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma

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 HER2-positive metastatic castration-resistant prostate adenocarcinoma who have progressed on androgen deprivation and novel hormonal agents (with or without prior taxane) and are not candidates for/declined taxanes receive fam-trastuzumab deruxtecan-nxki (Enhertu), an anti-HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor payload. Key exclusions include prior HER2-targeted therapy and history of ILD/pneumonitis; ongoing ADT and ECOG 0–1 required.

ClinicalTrials.gov ID: NCT06610825

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled 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: Men with metastatic castration-sensitive prostate cancer on stable androgen deprivation ± ARPI who are not currently doing regular resistance training are randomized to a home-based, telehealth-guided resistance training program plus creatine monohydrate vs the same program plus placebo. Creatine (a dietary supplement that increases intramuscular phosphocreatine to enhance exercise adaptations) is evaluated for preserving lean mass and improving function and metabolic health; patients with recent chemo or significant renal impairment are excluded.

ClinicalTrials.gov ID: NCT06112990