NCT05262608

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

A Multi-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Monotherapy in Newly Diagnosed mCRPC Patients Who Progressed on NHA and With HRR Gene Mutation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer
• Prostate Carcinoma
• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily

Timeline

• Start date: 2021-12-07
• Primary completion: 2024-02-26
• Completion: 2024-04-26
• First posted: 2022-03-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: China