Clinical Trials for Prostate Cancer

Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

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 asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (ECOG 0–1) receive an extended-course of sipuleucel-T autologous cellular immunotherapy (leukapheresis/infusions at weeks 0, 2, and 12–14). Sipuleucel-T consists of ex vivo–activated autologous antigen-presenting cells loaded with a PAP–GM-CSF fusion protein to induce PAP-specific T-cell and humoral responses; study explores feasibility, immunogenicity, and PSA changes.

ClinicalTrials.gov ID: NCT05806814

A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation

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 cancer showing neuroendocrine differentiation (by histology, molecular features such as PTEN/TP53/RB loss, clinical behavior, or elevated neuroendocrine markers) and SSTR-positive disease on Ga-68 DOTATATE PET receive 177Lu-DOTATATE every 6 weeks for up to 4 cycles. 177Lu-DOTATATE is a radiolabeled somatostatin analog delivering beta radiation to somatostatin receptor–expressing lesions; prior chemotherapy and treated/stable CNS metastases are allowed.

ClinicalTrials.gov ID: NCT05691465

GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy

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 study for men with metastatic CRPC progressing after ADT plus at least one ARPI (abiraterone/enzalutamide/apalutamide/darolutamide), allowing prior PSMA therapies or chemotherapy, ECOG 0–2. Patients receive oral GZ17-6.02 (curcumin/harmine/isovanillin; proposed NF-κB/kinase-modulating, pro-apoptotic activity) at 375 mg BID to assess safety and signals of efficacy with a primary endpoint of ≥6-month rPFS.

ClinicalTrials.gov ID: NCT06636123

A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation

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 hormone-sensitive prostate cancer within ~1 year of starting ADT (with or without docetaxel or an AR pathway inhibitor) who have residual FDG-avid lesions after ~6 months of systemic therapy are randomized to continue SOC with or without FDG-PET–guided metastasis-directed radiotherapy (stereotactic/conformal RT to up to 5 sites). Aims to consolidate oligopersistent disease to improve progression-free outcomes versus SOC alone.

ClinicalTrials.gov ID: NCT06244004

A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Advanced 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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 androgen-sensitive prostate cancer (locally advanced/metastatic or localized not suitable for curative therapy) who are candidates for continuous ADT are randomized to intramuscular Debio 4228, an extended‑release formulation of the GnRH antagonist degarelix, given as single-dose or loading plus 12‑week maintenance regimens. The study evaluates PK/PD and safety to identify a dose that rapidly achieves and maintains castrate testosterone without flare; enzalutamide coadministration is permitted but other combination ADT is excluded.

ClinicalTrials.gov ID: NCT06395753

A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide

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 advanced prostate adenocarcinoma eligible for abiraterone/prednisone or darolutamide (typically on concurrent ADT or post-orchiectomy) receive physician’s-choice standard therapy to compare tolerability and PSA response. Abiraterone (CYP17A1 inhibitor) is given with prednisone, versus darolutamide (androgen receptor antagonist with low CNS penetration) as monotherapy.

ClinicalTrials.gov ID: NCT06173362

Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer

Active drug

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

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 (progressed after ≥2 prior systemic regimens including a second‑generation AR‑targeted agent; PSA ≥4; progression within 6 months) receive the investigational PSMA×CD3 T‑cell–redirecting bispecific REGN4336 alone or combined with cemiplimab (anti–PD‑1) or REGN5678/nezastomig (PSMA×CD28 costimulatory bispecific), with step‑up dosing and optional IL‑6 blockade to mitigate CRS. Prior PSMA radioligand therapy is allowed; PSMA‑targeted non‑radioligand therapies are excluded.

ClinicalTrials.gov ID: NCT05125016

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive 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.

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 newly diagnosed metastatic hormone‑naive prostate adenocarcinoma within 42 days of starting ADT receive abiraterone acetate plus low‑dose prednisone until progression, with PSA response and outcomes correlated with race/ethnicity, baseline PSA decline, and germline variants in androgen metabolism pathways. Excludes prior chemo for metastatic disease and significant cardiac comorbidity; aims to enroll a racially diverse cohort (about half African American).

ClinicalTrials.gov ID: NCT03833921

Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) Trial

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 men with mCRPC progressing after abiraterone (ECOG 0–2) receive sequential cycles of DFMO (eflornithine; irreversible ornithine decarboxylase inhibitor targeting polyamine synthesis) with high‑dose testosterone (BAT) followed by enzalutamide, while continuing castration. Prior AR-targeted agents, taxanes, PARP inhibitors, radiopharmaceuticals, and prior BAT are allowed; key exclusions include opioid-requiring pain, high-flare risk sites, significant hearing loss, and seizure risk.

ClinicalTrials.gov ID: NCT06059118

Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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 mCRPC progressing on continuous androgen suppression after at least one AR signaling inhibitor and one chemotherapy, with measurable and biopsiable disease, receive bipolar androgen therapy: intramuscular testosterone cypionate every 28 days for 3 cycles while maintaining medical castration with leuprolide. The approach cycles testosterone from castrate to supraphysiologic levels to modulate androgen receptor signaling and potentially re-sensitize tumors, with assessments of AR activity, PSA response, and safety.

ClinicalTrials.gov ID: NCT06305598