Clinical Trials for Prostate Cancer

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation

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: This trial enrolls adults with advanced pancreatic, prostate, breast, or ovarian cancers harboring pathogenic or likely pathogenic germline BRCA2 and/or PALB2 mutations (with an exploratory cohort for other HRD-associated ovarian/fallopian/peritoneal cancers), treating them with intravenous CX-5461, a G-quadruplex DNA stabilizer that selectively targets homologous recombination–deficient tumor cells. Prior PARP inhibitor and systemic therapies are allowed, and patients must have measurable disease and ECOG ≤2.

ClinicalTrials.gov ID: NCT04890613

A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY 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.

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 with advanced solid tumors, primarily HR+/HER2- breast cancer refractory to standard therapies, and tests PF-07220060 (atirmociclib)—a selective oral CDK4 inhibitor with reduced expected hematologic toxicity—given alone or in combination with standard endocrine therapies or enzalutamide. Select other tumor types, including HR+/HER2+ breast cancer, NSCLC, prostate, colorectal cancer, liposarcoma, and CDK4/CCND1-amplified tumors, are also eligible.

ClinicalTrials.gov ID: NCT04557449

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant 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: This trial enrolls adults with advanced or metastatic solid tumors (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT04485013

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).

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 DLL3-expressing advanced neuroendocrine cancers—including relapsed/refractory SCLC after platinum, treatment-emergent or de novo neuroendocrine prostate cancer, and other high-grade NETs lacking effective options—receive gocatamig (HPN328), a trispecific T-cell engager targeting DLL3/CD3 with albumin-binding for half-life, as IV monotherapy on varied schedules or in combination with atezolizumab (PD-L1 inhibitor) or ifinatamab deruxtecan (B7-H3 ADC). Key exclusions include active/untreated CNS disease, significant autoimmune/immunosuppression, recent major cardiovascular events, uncontrolled viral infections, and interstitial lung disease.

ClinicalTrials.gov ID: NCT04471727

(ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary

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 and children (ECOG 0–3) with newly diagnosed oligometastatic lung, colorectal, or prostate cancer (1–10 lesions; brain mets excluded) are randomized to immediate stereotactic ablative radiotherapy (SABR) to all treatable sites plus standard systemic therapy versus initial standard therapy with SABR delayed ~6 months; a separate cohort allows immediate SABR for broader oligometastatic/oligoprogressive disease. Compares survival/ADT-free survival and safety/quality of life while standard systemic regimens are given per tumor type.

ClinicalTrials.gov ID: NCT06563388

A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

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: Enrolling adults with advanced solid tumors or lymphomas, including molecularly defined cohorts such as ARID1A-mutant endometrial/ovarian clear cell and other solid tumors, BAP1-loss mesothelioma, PTCL/DLBCL (including EZH2-mutant), and mCRPC. Investigational therapy is tulmimetostat (CPI-0209), an oral dual EZH2/EZH1 inhibitor, given as monotherapy across cohorts and combined with enzalutamide in mCRPC.

ClinicalTrials.gov ID: NCT04104776

Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)

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 aggressive, PSMA-PET–positive mCRPC after at least one AR pathway inhibitor (often post-docetaxel) are randomized to cabazitaxel plus carboplatin versus 177Lu-PSMA-617 radioligand therapy (binds PSMA to deliver beta-emitting lutetium-177). Eligible patients have high-risk features (e.g., visceral disease, ≥5 bone mets, lower PSMA SUVmean, or TP53/PTEN/RB1 alterations) and ECOG 0–2.

ClinicalTrials.gov ID: NCT06738303

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic 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.

HealthScout AI summary: Men with de novo metastatic prostate adenocarcinoma who complete 22–28 weeks of guideline-concordant ADT-based systemic therapy without progression (castrate T, PS 0–1) are randomized to continue systemic therapy alone versus adding definitive treatment of the primary (radical prostatectomy or definitive prostate radiation). Systemic therapy may include surgical or medical castration (LHRH agonists/antagonist), first-generation antiandrogens, and/or abiraterone; docetaxel allowed only during induction.

ClinicalTrials.gov ID: NCT03678025

A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog

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: Asymptomatic or minimally symptomatic mCRPC patients with PSA-only progression on continuous ADT plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) and no visceral disease are randomized to receive sipuleucel‑T with the NHA continued versus stopped. Sipuleucel‑T is an autologous cellular immunotherapy activating APCs ex vivo with a PAP–GM‑CSF fusion protein; NHAs include the androgen biosynthesis inhibitor abiraterone (with prednisone) and AR signaling inhibitors enzalutamide/apalutamide.

ClinicalTrials.gov ID: NCT05751941

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 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.

HealthScout AI summary: Adults with metastatic castration-resistant prostate cancer on continuous androgen suppression, including post–novel hormonal therapy and often post-taxane, receive xaluritamig (AMG 509), a STEAP1×CD3 bispecific T‑cell engager, as IV or SC monotherapy or in combination with abiraterone or enzalutamide. Excludes small cell/neuroendocrine histology and untreated CNS disease; aims to define dosing while assessing early antitumor activity.

ClinicalTrials.gov ID: NCT04221542