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

Prostatic Neoplasms Clinical Trial

— PROCeed-BR  

Official title:

Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone Observational Study Assessing Real World Clinical Endpoints and Demographic Characteristics in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457854
• Other study ID #: D0817R00083
• Status: Not yet recruiting
• Start date: July 20, 2024
• Est. completion date: September 23, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

PROCeed is an observational, longitudinal study with prospective data from Brazilian participating sites, so as to generate real-world data. 10 Brazilian oncology sites are estimated to participate in the study. Each site will have participating investigators in charge and a proper technical team who will be in charge of data from each service. For this study, a convenience sample will be adopted, with an expected 2-year recruitment of 80 patients. The protocol was created in Germany and other countries could use it, with the potential for data from other countries to be pooled for analysis. Recruitment to each subgroup will be monitored every 3 months and feasibility for continued enrolment will be assessed after 1 year of recruitment (at months 3 and 6, recruitment will be evaluated for proper site selection); if <20 patients have only been enrolled in a particular subgroup after 1 year, the study team will assess feasibility of pooling data from other countries to allow for at least 40 patients in a pooled analysis for that subgroup. The study plans to recruit patients for no more than 2 years and to follow patients from the start of olaparib to 1 year after last patient inclusion (LPI). Data will be collected from the medical record through an electronic case report form (eCRF). Participating physicians will be responsible for ensuring that all necessary data are collected and entered in the eCRF. Data compilation will be performed by the principal investigator and statistical analysis will be performed by the statistics team appointed by the Academic Research Organization (ARO). The target sample size of 80 patients in Brazil is based in a 24-month recruitment period. In order to avoid unnecessary imprecision for the subgroup previously exposed to a new hormonal agent, a minimum enrolment of 50% (40 patients) of the total sample size will be imposed for this subgroup. Estimation is determined based on the primary objective of the TTD event-free rate; the main measure of interest is at 6 months for patients previously exposed to NHA and 12 months for patients naïve to NHA. Assuming a 6- month TTD event-free rate is of approximately 50% for patients previously exposed to new hormonal agent, with a sample size of 40 patients in this subgroup, the precision would be +/- 15,5%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 23, 2025
• Est. primary completion date: September 23, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Willing to provide written informed consent;

2. 18 years or older;

3. Documented histology or cytology of PCa, adenocarcinoma;

4. Documented as mCRPC;

5. Olaparib+abiraterone started after the activation of the research site. Exclusion Criteria: Patients participating in a clinical trial with investigational treatment for prostate cancer within 30 days before starting olaparib.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
Brazil	Liga Norte Rio Grandense Contra o Câncer	Natal	Rio Grande Do Norte
Brazil	Clínica AMO	Salvador	Bahia
Brazil	Clínica Viver	Santa Maria	Rio Grande Do Sul
Brazil	Hospital Albert Einstein	São Paulo
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	To evaluate the time to progression of PSA.	This analysis will be performed only in patients with mCRPC 1L.	May 2026
Primary	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	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
Secondary	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
Secondary	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
Secondary	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