NCT05689021

CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 \[niraparib/abiraterone acetate fixed-dose combination\]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy of abiraterone acetate/niraparib (CJNJ-67652000 \[niraparib/abiraterone acetate fixed-dose combination\]) and prednisone as assessed by prostate-specific antigen decline \>= 50% (PSA50) response rate in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed prior treatment with androgen receptor (AR)-targeted therapy and have a qualifying, deleterious SPOP mutation. SECONDARY OBJECTIVES: I. To assess the radiologic progression free survival (rPFS) of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) and prednisone treatment in patients with mCRPC who have failed prior treatment with AR-targeted therapy and have a qualifying, deleterious SPOP mutation. II. To assess best radiographic response using Prostate Cancer Working Group 3 (PCWG3) criteria. III. To assess time to prostate specific antigen (PSA) progression. IV. To assess safety and tolerability using National Cancer Institute (NCI) Common Toxicity Criteria Version 5.0. CORRELATIVE RESEARCH OBJECTIVES: I. To explore the landscape of genomic alterations occurring after use of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) and prednisone. II. To use blood, tissue, or organoid lines for identifying predictive biomarkers of response, investigating drug resistance mechanisms, and for future drug efficacy studies. III. To explore the relationship of other genomic alterations in the tumor tissue with overall response rate (ORR) and disease progression. OUTLINE: Patients receive CJNJ-67652000 orally (PO) and prednisone PO on study. Patients also undergo blood specimen collection, computed tomography (CT) or magnetic resonance imaging (MRI), and bone scan throughout the trial.

Conditions

• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate/Niraparib	Given PO
PROCEDURE	Biospecimen Collection	Undergo blood specimen collection
PROCEDURE	Bone Scan	Undergo technetium-99m bone scan
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	Prednisone	Given PO

Timeline

• Start date: 2024-03-05
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-01-18
• Last updated: 2026-01-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study