All Trials

Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

TrialFetch AI summary: Metastatic castration-sensitive prostate cancer in men receiving standard ADT plus abiraterone/prednisone, adding talazoparib (a PARP inhibitor targeting DNA damage repair) to enhance disease control irrespective of homologous recombination repair status. Excludes prior chemo for metastatic disease; allows recent initiation of LHRH therapy and prior adjuvant ADT with testosterone recovery.

ClinicalTrials.gov ID: NCT04734730

Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

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 newly diagnosed de-novo oligometastatic prostate adenocarcinoma (ECOG 0–1) receiving 12 months of standard systemic therapy (ADT ± ARSI) plus definitive prostate-directed therapy are randomized to add metastasis-directed radiotherapy (stereotactic/hypofractionated RT to all metastatic sites by week 24) versus standard care alone. Excludes castration-resistant disease, visceral/intracranial metastases, prior definitive local/systemic therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT06150417

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects 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: Men with metastatic castration‑resistant prostate adenocarcinoma, including post–ARPI and typically post‑taxane (with expansion cohorts allowing taxane‑naïve or limited prior therapies), receive JANX007, a protease‑activatable PSMA×CD3 T‑cell engager designed to limit systemic T‑cell activation; an expansion cohort combines JANX007 with darolutamide. Excludes prior PSMA‑directed cellular/bispecific or radioligand therapies and significant comorbidities.

ClinicalTrials.gov ID: NCT05519449

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