Clinical trial · Observational
Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 1. Decentralized sites. 2. Lack of sites interest in the study. 3. Super estimate of potential patient numbers. 4. Transforming the protocol to a retrospective one could impact the study's publication timeline.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the real-world effectiveness, measured by Time to treatment discontinuation or death, of olaparib+abiraterone in 1L Castration-resistant prostate cancer
- timeFrame
- May 2026
- description
- 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 outcomes (4)
- measure
- 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.
- timeFrame
- May 2026
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available