Clinical Trials for Prostate Cancer

Phase II Trial of Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Selected Solid Tumor Malignancies

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.

Active drug

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

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.

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 advanced solid tumors after ≥1 prior therapy, enriched for ARID1A-altered cancers, ATM-deficient tumors (including mCRPC), and a post–checkpoint inhibitor endometrial cancer cohort; measurable disease required. Patients receive the ATR inhibitor ceralasertib (monotherapy for BAF250a-negative ARID1A or ATM-loss, ceralasertib + PARP inhibitor olaparib for BAF250a-positive ARID1A, or ceralasertib + anti–PD-L1 durvalumab for endometrial), leveraging DNA damage response targeting and potential synergy with PARP inhibition or immunotherapy.

ClinicalTrials.gov ID: NCT03682289

A Phase 2a Multicenter, Dose-Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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.

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.

HealthScout AI summary: Men with metastatic castration-resistant prostate adenocarcinoma after at least one second-generation AR inhibitor (± prior taxane), castrate and ECOG 0–2, with a lesion accessible for transperineal intratumoral access/biopsy, and without visceral or brain metastases. Treatment involves partial oncolysis of a target lesion followed by intratumoral SV-102, a fixed-dose multi-agent immunotherapy (anti-CTLA-4, anti-PD-1, CD40 agonist, TLR9 agonist) designed to induce in situ vaccination; dose is escalated/optimized across cohorts.

ClinicalTrials.gov ID: NCT06533644

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Active drug

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

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 castration-resistant prostate cancer that has radiographic/PSA progression on abiraterone or enzalutamide (with ongoing ADT) receive tinengotinib combined with their current ARSI (abiraterone/prednisone or enzalutamide). Tinengotinib is an oral spectrum-selective multikinase inhibitor (targets Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, CSF1R) aiming to enhance antitumor activity in this post-ARSI setting.

ClinicalTrials.gov ID: NCT06457919

Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

Active drug

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

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 adenocarcinoma after progression on at least one AR-targeted agent (and up to two prior taxanes or taxane-ineligible) are randomized to lutetium Lu 177 vipivotide tetraxetan alone versus in combination with ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody designed to preserve CTLA-4 recycling and selectively deplete intratumoral Tregs to potentially reduce immune toxicity. Requires ECOG 0–1, castrate testosterone, evidence of progression, and no prior PSMA radioligand therapy or active autoimmune disease.

ClinicalTrials.gov ID: NCT05682443

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

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

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.

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: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors—including SCLC, NSCLC, ESCC, CRPC, melanoma, HCC, cervical cancer, HNSCC, and select rare cancers—who have progressed after or are intolerant to standard therapies. Patients receive DB-1311, an anti-B7-H3 antibody-drug conjugate linked to a topoisomerase I inhibitor, administered intravenously every 3 weeks.

ClinicalTrials.gov ID: NCT05914116

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

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.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

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.

HealthScout AI summary: Adults with metastatic castration‑resistant prostate adenocarcinoma after 1–2 prior next‑generation hormonal agents, on continued ADT, are randomized to the CYP11A1 inhibitor opevesostat (MK‑5684) with physiologic steroid replacement as monotherapy or combined with olaparib, docetaxel, or cabazitaxel. Opevesostat blocks steroidogenesis upstream of androgen synthesis to suppress AR signaling; combinations aim to define RP2D and assess antitumor activity.

ClinicalTrials.gov ID: NCT06353386

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for 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.

HealthScout AI summary: Metastatic castration‑resistant prostate adenocarcinoma (ECOG 0–1; measurable or evaluable disease; PSA ≥2) treated with a combination of pasritamig (JNJ‑78278343), a KLK2×CD3 bispecific T‑cell–redirecting antibody, plus JNJ‑95298177 (ARX517), a PSMA‑targeted antibody–drug conjugate with a noncleavable microtubule inhibitor payload. Excludes prior KLK2‑directed therapy, recent T‑cell redirectors or checkpoint inhibitors, and prior PSMA radioligands for most expansion parts; aims to define an RP2CD and assess safety and preliminary activity.

ClinicalTrials.gov ID: NCT07082920