Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone

NCT06457854 | Withdrawn

• 1 other identifier: D0817R00083
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  May 2026

• Describe the treatments received before and after olaparib+abiraterone in general population and also in each population.

  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.

  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.

  May 2026

Other Outcomes (6)

• To evaluate the real world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L mCRPC

  May 2026

• To evaluate additional clinical outcomes (OS, rwPFS) in general population and also in each population

  May 2026

• Describe the dosage in patients treated with the combination of olaparib+abiraterone in general population and also in each population

  May 2026

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mens with documented histology or cytology of PCa and adenocarcinoma and Documented as mCRPC. This population needs to be 18 years or older. The treatment with Olaparib+abiraterone needs to start after the activation of the research site.

You may qualify if:

• Willing to provide written informed consent;
• years or older;
• Documented histology or cytology of PCa, adenocarcinoma;
• Documented as mCRPC;
• Olaparib+abiraterone started after the activation of the research site.

You may not qualify if:

• Patients participating in a clinical trial with investigational treatment for prostate cancer within 30 days before starting olaparib.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Clínica AMO

Salvador, Estado de Bahia, 41950640, Brazil

Location

Liga Norte Rio Grandense Contra o Câncer

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

Clínica Viver

Santa Maria, Rio Grande do Sul, 97015-450, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, 01327-001, Brazil

Location

Hospital Albert Einstein

São Paulo, 05652900, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Henrique Helber

  Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein Centro de Ensino e Pesquisa Albert Einstein

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 13, 2024
• Study Start: January 1, 2025
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BR (5)