Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03413995
Phase
PHASE2
Status
Completed

Conditions

  • Prostate Cancer Metastatic

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and who have an inherited mutation in a gene involved in repairing DNA damage. The research will also examine if rucaparib is safe in individuals with metastatic prostate cancer. Prior research studies have shown that drugs like rucaparib can be of benefit to patients with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an effective treatment for these patients earlier in their treatment course (for example, prior to the start of medicines that lower testosterone level). It is unknown whether rucaparib will have the same benefit in men with metastatic prostate cancer carrying a mutation in a DNA repair gene, prior to the use of medicines that lower your testosterone level.

Key Dates

Start date
Sep 10, 2018
Status verified
Sep 2024
Primary completion
Nov 8, 2023
Completion
Sep 12, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib 600 mg BID, continuous dosing
    Rucaparib 600mg by mouth twice daily, continuous dosing

Primary Outcome Measure

Number of Participants With Prostate Specific Antigen (PSA) >=50 Response [ Time Frame: 4 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21205-
Weill Cornell Medical CollegeNew YorkNew York10065-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MDWeill Cornell Medical College· New York, NY

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