Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer

Recruiting

• Conditions: Prostate Cancer; Castrate Resistant Prostate Cancer; BRCA Mutation
• Interventions: Drug: Olaparib

• Registration Number: NCT06783127
• Lead Sponsor: Santa Chiara Hospital

Brief Summary

This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 3000

Inclusion Criteria

BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice

Exclusion Criteria

Olaparib treatment in a clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mCRPC treated with olaparib	Olaparib	mCRPC patients who receive olaparib in daily clinical practice

Primary Outcome Measures

Name	Time	Method
disease control	From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months	projected survival from treatment start

Secondary Outcome Measures

Name	Time	Method
biochemical response	Through study completion, an average of 1 years	rate of patients with PSA reduction \> 50%
response rate	Through study completion, an average of 1 years	rate of patients with measurable disease showing partial or complete response
PFS	From the date of treatment start until the date of first progression or date of death from any cause, whichever came first, assessed up to 120 months	projected survival without progression
toxicity rate	Through study completion, an average of 1 years	toxicity recorded during the treatment

Trial Locations

Locations (2)

Sabrina Rossetti; 🇮🇹 Napoli, Italy

Orazio Caffo; 🇮🇹 Trento, Italy