Clinical Trials for Prostate Cancer

TIDAL: Phase 2 Study of Tarlatamab in Patients With Delta-like Protein 3 (DLL3) Positive Metastatic Prostate Cancer

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 DLL3-positive metastatic prostate cancer (including de novo small cell/neuroendocrine) after at least one prior metastatic-line therapy and with castrate testosterone (unless de novo NEPC) receive tarlatamab, a DLL3×CD3 bispecific T‑cell engager given with step-up dosing. Eligibility requires ≥50% DLL3 expression by CLIA IHC, ECOG 0–2, measurable/assessable progression; excludes prior DLL3 therapy and significant uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT07111507

A Study of 7-days Water-only Fasting in Patients With Metastatic Prostate Cancer

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: Single-center, single-arm study enrolling adults with metastatic prostate adenocarcinoma (ECOG 0–1, BMI 20–35) and non-declining PSA to undergo a 7-day water-only fast with optional switch to a ketogenic very low-calorie diet, followed by a 3-day refeed. Evaluates safety/feasibility of the dietary intervention with monitoring of adverse events, patient-reported outcomes, and activity.

ClinicalTrials.gov ID: NCT06826924

A Randomized Trial of High-risK metachroNous oligometastatIc Prostate Cancer With hiGh-risk Mutations Treated witH meTastasiS Directed Therapy and Niraparib/Abiraterone Acetate and Prednisone (KNIGHTS)

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 metachronous oligometastatic, castration‑sensitive prostate adenocarcinoma (1–3 sites; high‑risk pathogenic mutations such as BRCA1/2, PALB2, TP53, CHEK2, etc.) are randomized to standard ADT plus SABR to all lesions versus the same with 6 months of niraparib (PARP inhibitor exploiting HRR defects) combined with abiraterone acetate (CYP17 inhibitor) and prednisone. Suitable for ECOG 0–2, PSA >0.5–<50, PSADT <15 months, baseline testosterone >100 ng/dL; excludes prior PARP inhibitor use and disease/features precluding SABR.

ClinicalTrials.gov ID: NCT06212583

Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)

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 biopsy-proven intraprostatic recurrence after prior EBRT (no extraprostatic/nodal disease; MRI-visible lesion; good performance status; prostate <90 cc; IPSS ≤20) receive MR-Linac–guided, adaptively planned SBRT plus 4–6 months of ADT as salvage therapy. The study evaluates late grade ≥3 GU/GI toxicity and efficacy endpoints (biochemical control, metastasis-free survival, and radiographic response).

ClinicalTrials.gov ID: NCT07142967

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate 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: Adults with PSMA-positive metastatic castration-resistant prostate cancer after at least one second-generation AR pathway inhibitor (chemotherapy excluded in expansion) undergo 64Cu‑SAR‑bisPSMA PET/CT for selection/dosimetry followed by up to four cycles of 67Cu‑SAR‑bisPSMA, a bivalent PSMA‑targeted beta‑emitting radiotherapeutic; an expansion cohort allows concomitant enzalutamide. Excludes brain mets, small cell/neuroendocrine histology, significant comorbidities, and PSMA‑negative progressing lesions (except in early phases).

ClinicalTrials.gov ID: NCT04868604

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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 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.

TrialFetch 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