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NCT05689021 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Mayo Clinic.

Active
Registry status
Phase 2
Development phase
8
Enrollment target
3
Study locations

NCT05689021: Active Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Mayo Clinic.

NCT05689021 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 8 participants, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05689021, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is active but no longer recruiting, sponsored by Mayo Clinic.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
8 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

PSA50 response rate is defined as \> 50% PSA decrease as compared to baseline. The proportion of PSA responses will be estimated by the number of PSA responses divided by the total number of evaluable patients. 95% exact binomial confidence intervals will be computed. The frequency and relative frequency of individual PSA response categories will also be computed. In addition, the maximum percentage change for PSA will be computed and displayed graphically via waterfall plots for individual pati

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Bone Scan
  • DRUG Abiraterone Acetate/Niraparib

Study Locations (3)

Arizona

  • Mayo Clinic in Arizona - Scottsdale

Florida

  • Mayo Clinic in Florida - Jacksonville

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2024-03-05
Est. Completion 2026-03-31
Phase Phase 2
Mayo Clinic

2,844 total trials

What the registry record for NCT05689021 still lists

NCT05689021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (95% lower).

The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05689021 reports a single indexed study location in Arizona, Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT05689021 about?

NCT05689021 is a clinical study titled "CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations". 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 ...

What is the current status of trial NCT05689021?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2024-03-05. Estimated completion is 2026-03-31.

What conditions does trial NCT05689021 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma.

What interventions are being tested in trial NCT05689021?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Abiraterone Acetate/Niraparib (DRUG).

Who is sponsoring clinical trial NCT05689021?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05689021 being conducted?

This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IVB Prostate Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05689021's enrollment target sits among peer trials

8 43rd of 45 higher than 3 of 45 other Stage IVB Prostate Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05689021, the US trial registry maintained by the National Library of Medicine. NCT05689021 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.