Prostatic Neoplasms
Conditions
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.
Detailed 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%.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the real-world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L Castration-resistant prostate cancer | May 2026 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Describe the treatments received before and after olaparib+abiraterone in general population and also in each population. | May 2026 | 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). |
| 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 | 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). |
| 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 | This analysis will be performed in mCRPC 1L patients (base case analysis) and in all patients with mCRPC (sensitivity analysis). |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the real world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L mCRPC | May 2026 | 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. |
| To evaluate the time to progression of PSA. | May 2026 | This analysis will be performed only in patients with mCRPC 1L. |
| To evaluate additional clinical outcomes (OS, rwPFS) in general population and also in each population | May 2026 | 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. |
| Describe the dosage in patients treated with the combination of olaparib+abiraterone in general population and also in each population | May 2026 | 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). |
| Describe the reasons for dose change/discontinuation in patients treated with the combination of Olaparib+Abiraterone in general population and also in each population | May 2026 | 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). |
| To evaluate the PSA25 and PSA50 response with an evaluation tool to predict the practical clinical activity in the real world. | May 2026 | This analysis will be performed only in patients with mCRPC 1L. |
Countries
Brazil
Outcome results
None listed