Clinical Trials for Prostate Cancer

Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced 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: Enrolling adult men with advanced prostate cancer across disease states, including mCRPC (expansion cohorts require prior abiraterone or exactly one prior ARPI), with ECOG 0–1 and adequate organ function. Investigational treatment is intramuscular PRL-02 (abiraterone decanoate), a long-acting CYP17 inhibitor depot given every 12 weeks with prednisone or dexamethasone, with or without enzalutamide depending on cohort.

ClinicalTrials.gov ID: NCT04729114

A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN 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 hormone-sensitive oligorecurrent prostate adenocarcinoma confined below the diaphragm (≤5 PSMA PET/CT–positive lesions with at least one para-aortic node, no bone/visceral mets) after prior pelvic RT receive PSMA-PET–directed para-aortic radiation (photon or proton) plus up to 6 months of ADT and an androgen receptor signaling inhibitor. Aims to improve disease control and delay escalation, with PFS and patient-reported outcomes tracked.

ClinicalTrials.gov ID: NCT06392295

A First-in-Human, Open-label, Dose Escalation and Expansion Study of Orally Administered JBI-802 in Patients 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: Single-arm study of JBI-802, an oral first-in-class dual LSD1/HDAC6 inhibitor targeting the CoREST complex, for adults with advanced solid tumors; dose-escalation includes broadly refractory tumors, and expansion focuses on neuroendocrine-derived cancers (e.g., SCLC post ≤2 lines including platinum/IO, de novo or treatment-emergent neuroendocrine prostate cancer, and other neuroendocrine tumors). Key eligibility: ECOG 0–2, measurable disease, adequate organ function; prior treated/stable brain mets allowed; excludes MSS CRC and HCC in dose escalation and patients on strong CYP3A/2D6 modulators.

ClinicalTrials.gov ID: NCT05268666

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in De Novo OligometaStatic Prostate Cancer (TERPS) 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 de novo oligometastatic, hormone-sensitive prostate cancer (ECOG 0–2; 1–3 mets on conventional imaging with ≥1 bone, or up to 5 on PET) receive standard systemic therapy plus definitive prostate radiotherapy, randomized to add stereotactic ablative radiotherapy (SABR) to all metastatic sites versus no SABR. Prior short-course ADT/systemic therapy allowed; key exclusions include castration-resistant disease and bulky visceral metastases.

ClinicalTrials.gov ID: NCT05223803

A Phase II Study of Bortezomib in Patients with Metastatic Castration-Resistant Prostate Cancer with PTEN Deletion

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: Biomarker-selected mCRPC patients with PTEN deletion after at least one AR pathway inhibitor and no prior chemotherapy for mCRPC receive single-agent bortezomib (1.3 mg/m2 SC days 1, 4, 8, 11 every 21 days). Bortezomib is a reversible 26S proteasome inhibitor that may exploit PI3K/AKT pathway dysregulation in PTEN-loss tumors; key exclusions include ≥grade 2 neuropathy and uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT06029998

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

A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients With PSMA+ Advanced and/or Metastatic Solid Tumours

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 PSMA-positive advanced/metastatic solid tumors (including a combination cohort focused on mCRPC) receive CB307, an investigational trispecific Humabody that targets PSMA and albumin to conditionally activate CD137 (4-1BB) costimulation, given weekly IV; a separate cohort combines CB307 with pembrolizumab q3w. Key exclusions include active autoimmune disease/immunosuppression, CNS metastases, and prior PD-(L)1/CTLA-4 therapy in the combo cohort.

ClinicalTrials.gov ID: NCT04839991

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