Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone
NCT Number: NCT06457854
Acronym: PROCeed-BR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostatic Neoplasms
Sponsor: AstraZeneca
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2025-09-23
Locations: Clínica AMO, Salvador, Bahia, 41950640, Brazil|Liga Norte Rio Grandense Contra o Câncer, Natal, Rio Grande Do Norte, 59062-000, Brazil|Clínica Viver, Santa Maria, Rio Grande Do Sul, 97015-450, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, 01327-001, Brazil|Hospital Albert Einstein, São Paulo, 05652900, Brazil

Summary:
PROCeed is an observational study assessing real world clinical endpoints and demographic characteristics in patients with castration-resistant prostate cancer treated with Olaparib+Abiraterone.

Primary Outcome Measures: To evaluate the real-world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L Castration-resistant prostate cancer, Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. The main measure of interest is Time to treatment discontinuation or death (TTD) with corresponding 95% confidence intervals in 6-month and 12-month timepoints for subgroup 1 and subgroup 2, respectively. This analysis will be performed only in patients with Castration-resistant prostate cancer(mCRPC) 1L. Patients exposed to abiraterone pre- olaparib+abiraterone initiation will be excluded from this primary analysis, May 2026
Secondary Outcome Measures: Describe the demographic and clinical characteristics of Castration-resistant prostate cancer patients treated with olaparib+abiraterone in the general population and also in each population., Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. This analysis will be performed in Castration-resistant prostate cancer (mCRPC) 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis)., May 2026|Describe the treatments received before and after olaparib+abiraterone in general population and also in each population., Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. This analysis will be performed in mCRPC 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis)., May 2026|To evaluate Time to first subsequent therapy or death in patients with Castration-resistant prostate cancer treated with olaparib+abiraterone in general population and also in each population., Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. This analysis will be performed in mCRPC 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis)., May 2026|To describe the demographic data, clinical characteristics, previous and subsequent treatments of patients with mCRPC treated with olaparib+abiraterone in overall cohort and in subgroups 1 and 2, additionally stratified by BRCA/HRR mutation status., This analysis will be performed in mCRPC 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis)., May 2026
Other Outcome Measures: To evaluate the real world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L mCRPC, Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation (TTD rate (event- free) with corresponding 95% confidence intervals in 3, 9, 12 and 24-month timepoints and median TTD); Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. (TTD rate (event-free) with corresponding 95% confidence intervals in 3, 6, 9 and 24 -month timepoints and median TTD). Patients exposed to abiraterone pre-olaparib+abiraterone initiation will be excluded from this exploratory objective analysis. This analysis will also be performed only in patients with 1L mCRPC., May 2026|To evaluate additional clinical outcomes (OS, rwPFS) in general population and also in each population, Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to pre-olaparib+abiraterone initiation. Patients exposed to abiraterone pre-olaparib+abiraterone initiation will be excluded from this analysis. This analysis will also be performed only in patients with 1L mCRPC., May 2026|Describe the dosage in patients treated with the combination of olaparib+abiraterone in general population and also in each population, Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. This analysis will be performed in mCRPC 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis)., May 2026|Describe the reasons for dose change/discontinuation in patients treated with the combination of Olaparib+Abiraterone in general population and also in each population, Subgroup 1: patients exposed to NHA pre-olaparib+abiraterone initiation; Subgroup 2: patients not exposed to NHA pre-olaparib+abiraterone initiation. This analysis will be performed in mCRPC 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis)., May 2026|To evaluate the PSA25 and PSA50 response with an evaluation tool to predict the practical clinical activity in the real world., This analysis will be performed only in patients with mCRPC 1L., May 2026|To evaluate the time to progression of PSA., This analysis will be performed only in patients with mCRPC 1L., May 2026