Clinical Trials for Prostate Cancer

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

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 metastatic prostate, urothelial, or renal cell carcinoma on a systemic regimen with overall benefit but ≤5 oligo-progressive lesions receive local ablation (SABR or IR ablation) to progressing sites while continuing the same systemic therapy. Aims to prolong disease control without changing systemic treatment; excludes intracranial progression or contraindications to ablation.

ClinicalTrials.gov ID: NCT06101290

A Phase 1 Open-label, Dose-finding Multi-center Trial of [177Lu]Ludotadipep in Metastatic Castration-resistant Prostate Cancer Patients, Followed by an Open-label, Repeat Dose, Multi-center Phase 2a Trial to Assess Safety and Efficacy

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.

HealthScout AI summary: Men with PSMA-positive metastatic castration-resistant prostate cancer after at least one AR pathway inhibitor (taxane-exposed, ineligible, or declining allowed) receive [177Lu]Ludotadipep, a lutetium-177 beta-emitting PSMA-targeted radioligand with albumin-binding to enhance tumor uptake, given as a single dose for dose-finding followed by repeat dosing every ~8 weeks. Excludes prior PSMA radioligand therapy and requires adequate organ function and ECOG 0–2 (Phase 1) or 0–1 (Phase 2a).

ClinicalTrials.gov ID: NCT05458544

An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With 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.

HealthScout AI summary: Adults with metastatic prostate cancer on castrate testosterone, including mCRPC after prior ARPI (and limited prior chemo), receive the investigational oral EED-directed PRC2 inhibitor ORIC-944 as monotherapy or combined with an ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide). The trial seeks safety/PK and early activity, with dose-escalation/optimization cohorts stratified by prior ARPI exposure.

ClinicalTrials.gov ID: NCT05413421

A Phase 2 Study of Biomarker-Modulated PSMA Theranostics

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 metastatic castration‑resistant prostate cancer after at least one AR pathway inhibitor and 1–2 prior taxanes receive 177Lu‑PSMA‑617 radioligand therapy, with intensified, biomarker‑modulated dosing up to six cycles. 177Lu‑PSMA‑617 targets PSMA to deliver beta radiation from lutetium‑177 to tumor cells, and the study assesses PSA progression-free survival and safety.

ClinicalTrials.gov ID: NCT06526299

A Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

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.

HealthScout AI summary: Adults with metastatic non‑prostate genitourinary cancers (e.g., urothelial, renal cell, germ cell) receive bintrafusp alfa (anti–PD‑L1/TGF‑β trap) plus PDS01ADC/NHS‑IL12 (tumor‑targeted IL‑12 immunocytokine), with or without SBRT to up to four lesions, to assess safety and dosing. Prior systemic therapy and checkpoint inhibitors are allowed; SBRT cohorts require at least one irradiable lesion and one non‑irradiated measurable lesion.

ClinicalTrials.gov ID: NCT04235777

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.

HealthScout 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.

HealthScout 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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of 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 high-risk biochemical recurrence of prostate adenocarcinoma (PSA doubling time <12 months) after prior local therapy, testosterone ≥150 ng/dL, ECOG 0–1, and at least one PSMA PET/CT–positive lesion without metastases on conventional imaging are randomized to ADT plus darolutamide vs ADT plus placebo for 24 months. Darolutamide is a second‑generation androgen receptor inhibitor that blocks AR binding/nuclear translocation with low CNS penetration.

ClinicalTrials.gov ID: NCT05794906

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.

HealthScout 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.

HealthScout 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