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NCT05262608: PROspect

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

Status unknown Phase 2 Last updated 2 March 2022
What this trial tests

Phase 2 trial testing Olaparib in Prostate Cancer in 30 participants. Status unknown.

Timeline
7 December 2021
Primary endpoint
26 February 2024
26 April 2024

Quick facts

Lead sponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date7 December 2021
Primary completion26 February 2024
Estimated completion26 April 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

18 and older, male only, with Prostate Cancer or Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Androgen Receptor Signaling Inhibition in Advanced Castration Resistance Prostate Cancer: What Is Expected for the Near Future?
    Pozas J, Álvarez Rodríguez S, Fernández VA, Burgos J, et al · · 2022 · cited 16× · PMID 36551557 · DOI 10.3390/cancers14246071
  2. Effect of ubiquitin protease system on DNA damage response in prostate cancer (Review).
    Lin Y, Jin X. · · 2024 · cited 6× · PMID 38125344 · DOI 10.3892/etm.2023.12321

Verify or expand the search:

Other trials of Olaparib

Trials testing the same drug.

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials

Trials by the same sponsor.

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Data sources for this page

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