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PARP Inhibitor

CJNJ-67652000 + Prednisone for Prostate Cancer

Phase 2

Recruiting

Led By Daniel S. Childs, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to the earliest date of documentation of progression, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug combo to treat metastatic prostate cancer with SPOP gene mutation. Drug combo stops cancer cells from repairing, prednisone reduces inflammation & immune response. May kill more tumor cells than either alone.

Who is the study for?

Men aged 18+ with advanced prostate cancer resistant to castration and spread beyond the original site, having specific SPOP gene mutations. They can have had one prior chemotherapy but must be in relatively good health (ECOG status 0-2) with adequate blood counts and organ function. Men must agree not to donate sperm and use contraception during the trial.

What is being tested?

The effectiveness of CJNJ-67652000 (a combination of niraparib/abiraterone acetate) alongside prednisone is being tested for treating metastatic castration-resistant prostate cancer with SPOP mutations. The study will assess if this drug combo kills more tumor cells compared to standard treatments.

What are the potential side effects?

Potential side effects include those typical of cancer therapies such as fatigue, digestive issues, changes in blood counts leading to increased infection risk, possible liver or kidney function changes, and reactions related to steroid use like increased blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to the earliest date of documentation of progression, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to the earliest date of documentation of progression, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to the earliest date of documentation of progression, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prostate specific antigen (PSA) response rate (PSA decline by >= 50% [PSA50])

Secondary study objectives

Incidence of adverse events

Radiologic progression-free survival (rPFS)

Time to progression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CJNJ-67652000 and prednisone)Experimental Treatment6 Interventions

Patients receive CJNJ-67652000 PO and prednisone PO on study. Patients also undergo blood specimen collection, CT or MRI, and bone scan throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Biospecimen Collection

2004

Completed Phase 3

~2020