Study on CJNJ-67652000 and Prednisone for Treating Advanced Prostate Cancer with SPOP Gene Mutations

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05689021

Provider View

This clinical trial is exploring the effectiveness of a new drug combination, CJNJ-67652000 (niraparib/abiraterone acetate) and prednisone, in treating men with advanced prostate cancer that has spread and has a specific gene mutation. The study aims to see if this combination can kill more cancer cells than using the drugs separately.

Patient Parameters

Program Overview

This phase II study is testing how well a combination of drugs, CJNJ-67652000 (a mix of niraparib and abiraterone acetate) and prednisone, works in treating men with prostate cancer that has spread to other parts of the body and has a mutation in the SPOP gene. CJNJ-67652000 helps stop cancer cells from repairing themselves, leading to their death, while prednisone helps reduce inflammation and side effects of chemotherapy. The study aims to find out if this combination can kill more cancer cells than using the drugs alone.

Description

The main goal of this study is to see if the drug combination can lower prostate-specific antigen (PSA) levels by 50% or more in men with advanced prostate cancer that has not responded to previous treatments and has a specific SPOP gene mutation. Secondary goals include assessing how long patients live without the cancer getting worse, the best response seen on scans, the time it takes for PSA levels to rise again, and the safety of the treatment.

Researchers will also study changes in the cancer's genetic makeup after treatment and look for markers that might predict how well the treatment works or why it might stop working. Participants will take the study drugs orally and undergo regular blood tests, scans, and bone scans to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Confirmed diagnosis of prostate cancer.
  • Have a specific SPOP gene mutation.
  • Cancer has spread to other parts of the body and is resistant to hormone therapy.
  • Have tried at least one hormone therapy before.
  • Have not had more than two chemotherapy treatments.
  • Good overall health with an ECOG score of 0, 1, or 2.
  • Low testosterone levels due to medical or surgical treatment.
  • Meet specific blood test requirements.
  • Agree to use contraception during the study and for 120 days after the last dose.
  • Provide written informed consent.

Exclusion Criteria

  • Previous treatment with PARP inhibitors or platinum chemotherapy.
  • History of certain blood disorders.
  • Recent surgery or chemotherapy.
  • Severe health conditions that could interfere with the study.
  • Life expectancy of less than 16 weeks.
  • HIV positive with certain conditions.
  • Uncontrolled illnesses like heart failure or high blood pressure.
  • Other active cancers within the last 3 years, except for certain skin or cervical cancers.
  • Brain metastases causing symptoms.
  • Conditions that make prednisone use unsafe.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.