Clinical trial · Observational
Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)
A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.
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 |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to treatment discontinuation
- timeFrame
- Up to 12 months
- description
- Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively. TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.
Secondary outcomes (1)
- measure
- Time to first subsequent therapy
- timeFrame
- Up to 24 months
- description
- Time to first subsequent therapy (TFST) in mCRPC patients treated with olaparib + abiraterone. TFST is defined as the time from olaparib initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation or death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide written informed consent; * 18 years of age and above; * Documented histopathology or cytopathology of PCa, adenocarcinoma; * Confirmed as mCRPC; * Initiated olaparib + abiraterone after site activation Exclusion Criteria: * Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation
References
Publications (0)
Data not yet available