Clinical Trials for Prostate Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma

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 HER2-positive metastatic castration-resistant prostate adenocarcinoma who have progressed on androgen deprivation and novel hormonal agents (with or without prior taxane) and are not candidates for/declined taxanes receive fam-trastuzumab deruxtecan-nxki (Enhertu), an anti-HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor payload. Key exclusions include prior HER2-targeted therapy and history of ILD/pneumonitis; ongoing ADT and ECOG 0–1 required.

ClinicalTrials.gov ID: NCT06610825

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled 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: Men with metastatic castration-sensitive prostate cancer on stable androgen deprivation ± ARPI who are not currently doing regular resistance training are randomized to a home-based, telehealth-guided resistance training program plus creatine monohydrate vs the same program plus placebo. Creatine (a dietary supplement that increases intramuscular phosphocreatine to enhance exercise adaptations) is evaluated for preserving lean mass and improving function and metabolic health; patients with recent chemo or significant renal impairment are excluded.

ClinicalTrials.gov ID: NCT06112990

An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant 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.

HealthScout AI summary: PSMA-PET–positive, non-metastatic on conventional imaging, castration-resistant prostate cancer patients on continuous ADT are randomized to Lu-177–PSMA-617 radioligand therapy alone versus Lu-177–PSMA-617 plus an androgen receptor pathway inhibitor (enzalutamide, apalutamide, darolutamide, or abiraterone). Lu-177–PSMA-617 delivers targeted beta radiation to PSMA-expressing cells; the study aims to deepen PSA responses and delay metastasis.

ClinicalTrials.gov ID: NCT05849298

Phase 2 Study of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated with SPOP Mutation with or Without Homologous Recombination Deficiency

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: For adult men with mCRPC harboring a deleterious SPOP mutation after progression on androgen deprivation and at least one AR-targeted agent (up to two prior taxanes allowed), this single-arm study tests an oral fixed-dose combination of niraparib (PARP inhibitor) and abiraterone acetate (CYP17 inhibitor) plus prednisone. Excludes prior PARP or platinum therapy and requires ECOG 0–2 and adequate organ function; primary endpoint is PSA50 response.

ClinicalTrials.gov ID: NCT05689021

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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

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 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

TRAMP: Tumor Necrosis Factor- α Blockade and AR Inhibition in Men With CRPC

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 or non-metastatic CRPC after at least one novel hormonal therapy (± one prior taxane), ECOG 0–2, evaluating apalutamide combined with golimumab, a TNF‑α–neutralizing monoclonal antibody intended to modulate inflammation-driven resistance. Excludes small cell/neuroendocrine histology and patients with active/latent TB, significant infections, hepatitis B/C, HIV, seizure risk, or prior TNF‑α inhibitor use.

ClinicalTrials.gov ID: NCT05960578