Clinical Trials for Prostate Cancer

Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy

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

HealthScout AI summary: Men with PSMA PET–positive biochemical recurrence after definitive local therapy, no visceral/bone mets, testosterone >100 ng/dL, and PSA DT <12 months are randomized to short-course enzalutamide without ADT versus enzalutamide plus PDS01ADC (NHS-IL12), an IL‑12 immunocytokine that targets exposed histones in necrotic tumor regions to deliver IL‑12 and stimulate NK/T‑cell activity. Designed to test whether adding PDS01ADC prolongs PSA control; retreatment with enzalutamide alone allowed upon PSA return to baseline.

ClinicalTrials.gov ID: NCT06096870

A Phase 1b/2a, MultiCenter, Open- Label Study of Pocenbrodib as Monotherapy or in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 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: Men with imaging-confirmed mCRPC who have progressed after at least one potent AR pathway inhibitor; excludes small cell/neuroendocrine histology and liver metastases. Evaluates pocenbrodib, an oral CBP/EP300 bromodomain inhibitor that suppresses AR/AR‑variant transcription, as monotherapy and in combination with abiraterone, olaparib, or 177Lu‑PSMA‑617.

ClinicalTrials.gov ID: NCT06785636

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive 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: Adults with de novo, high-volume metastatic hormone-sensitive prostate adenocarcinoma on ADT (with or without recent darolutamide or abiraterone) and no prior docetaxel are treated with xaluritamig plus either darolutamide or abiraterone. Xaluritamig (AMG 509) is an investigational STEAP1×CD3 bispecific T‑cell engager; the study assesses safety and preliminary activity of these combinations.

ClinicalTrials.gov ID: NCT07140900

A Phase Ib Clinical Trial to Optimize Risk Benefit of REGN5678 (PSMAxCD28 Bispecific Antibody) Plus Cemiplimab (Anti-PD-1 Monoclonal Antibody) in Patients 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.

HealthScout AI summary: Men with metastatic castration‑resistant prostate cancer progressing after ≥2 prior systemic regimens (including a next‑generation AR pathway inhibitor), ECOG 0–1, and adequate organ function; prior PSMA‑targeted therapy and immunotherapy allowed. Treatment is REGN5678 (nezastomig), a PSMA×CD28 T‑cell costimulatory bispecific antibody with a weekly lead‑in then q3w dosing, combined q3w with the PD‑1 inhibitor cemiplimab.

ClinicalTrials.gov ID: NCT06826768

MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

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 (taxane-naive in the mCRPC setting) after 1–2 AR pathway inhibitors are randomized to ifinatamab deruxtecan (I-DXd, a B7-H3–targeting antibody–drug conjugate delivering a topoisomerase I inhibitor) alone or combined with MK-5684 (opevesostat, a CYP11A1 inhibitor suppressing steroidogenesis) or an ARPI (abiraterone or enzalutamide) versus docetaxel. Key exclusions include prior ILD/pneumonitis and prior taxane for mCRPC; endpoints include safety, PSA50, and radiographic efficacy.

ClinicalTrials.gov ID: NCT06863272

A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Black or African American men with locally advanced/high-risk, biochemically recurrent, or metastatic prostate cancer receive standard therapies first in clinic then at home with remote monitoring to compare safety and patient-centered outcomes. Eligible regimens for home administration include ADT (leuprolide, degarelix), cabazitaxel, pembrolizumab, and bone-modifying agents (zoledronic acid, denosumab); oral agents like second-generation antiandrogens or PARP inhibitors may be continued but oral-only regimens are excluded.

ClinicalTrials.gov ID: NCT07073794

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With 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.

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 ER+/HER2- breast cancer who have progressed after endocrine therapy and a CDK4/6 inhibitor, as well as selected patients with castration-resistant prostate cancer or non–small-cell lung cancer refractory to standard treatments. Participants receive PF-07248144, a selective KAT6A/B histone acetyltransferase inhibitor, as monotherapy or in combination with endocrine therapy or other investigational agents.

ClinicalTrials.gov ID: NCT04606446

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

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 relapsed or refractory small cell lung cancer, metastatic castration-resistant prostate cancer post-abiraterone/enzalutamide, or follicular lymphoma to receive mevrometostat, a selective oral EZH2 inhibitor, as monotherapy or in combination with standard of care therapies. Treatment assignment varies by disease type and prior therapy, with some arms randomizing mCRPC patients to mevrometostat plus standard of care versus standard of care alone.

ClinicalTrials.gov ID: NCT03460977

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

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 breast, ovarian, prostate, pancreatic (HRR-mutated), IDH1/2-mutant glioma, and other selected solid cancers—who have progressive disease and good performance status, testing the selective PARP1 inhibitor AZD9574 as monotherapy or in combination with temozolomide, trastuzumab deruxtecan, or datopotamab deruxtecan. Eligibility may require specific genetic or molecular features depending on tumor type and study module.

ClinicalTrials.gov ID: NCT05417594

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot 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: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329