The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05262608
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily

Study Details

This is a multi-center, single-arm, prospective study to assess the efficacy and safety of Olaparib in men with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) who carried homologous recombination repair (HRR) gene mutations and have progressed after treatment with novel endocrine agents (NHA) in the metastatic castration-sensitive prostate cancer or non-metastatic castration-resistant prostate cancer. A total of 30 newly diagnosed mCRPC subjects with radiologically evaluable disease at baseline who have progressed on prior NHA and carry HRR gene mutations that meet the criteria will be included in the study. Eligible subjects will receive a treatment regimen of oral Olaparib tablets 300 mg twice daily until disease progression or intolerance. During the treatment and follow-up periods, all subjects will have regular visits to assess the efficacy and safety of Olaparib. Data on objective radiographic response (ORR), prostate-specific antigen response (PSA response), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) will be collected during the study.

Key Dates

Start date
Dec 7, 2021
Status verified
Feb 2022
Primary completion
Feb 26, 2024
Completion
Apr 26, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention/Treatment
    Subjects will receive a regimen of Olaparib tablets 300 mg twice daily until radiographic disease progression (assessed by the investigator according to RECIST1.1 and PCWG 3) or intolerable adverse events (assessed by the investigator according to the actual clinical situation).

Primary Outcome Measure

Primary Outcome Measures 1 [ Time Frame: up to 60 months ]

Central Contacts

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