Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)

Recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer

• Registration Number: NCT06380738
• Lead Sponsor: AstraZeneca

Brief Summary

PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study Start: 2024-02-14
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

• Willing and able to provide written informed consent;
• 18 years of age and above;
• Documented histopathology or cytopathology of PCa, adenocarcinoma;
• Confirmed as mCRPC;
• Initiated olaparib + abiraterone after site activation

Exclusion Criteria

• Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment discontinuation	Up to 12 months	Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively.; TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Time to first subsequent therapy	Up to 24 months	Time to first subsequent therapy (TFST) in mCRPC patients treated with olaparib + abiraterone.; TFST is defined as the time from olaparib initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation or death due to any cause.

Trial Locations

Locations (1)

Research Site; 🇩🇪 Wetzlar, Germany