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

Prostate Cancer Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

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

• NCT number: NCT05262608
• Study type: Interventional
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Hao Liu
• Phone: +86-13560338664
• Email: liuh65@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: December 7, 2021
• Completion date: April 26, 2024