Clinical trial · Observational
PRostate Olaparib Real World Evidence Study
A French Observational Longitudinal Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration Resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
This French non-interventional longitudinal multicenter cohort study is conducted to study the added value of olaparib in the treatment of patients with mCRPC in the real world setting in terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus inform future clinical practice.
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 (TTD)
- timeFrame
- Up to 24 months from olaparib initiation
- description
- TTD is defined as the time from the first day of olaparib treatment to the day that olaparib stopped for whatever reason or the date of death due to any cause, whichever comes first
Secondary outcomes (28)
- measure
- Real-world Progression-free survival (rwPFS)
- timeFrame
- Up to 24 months from olaparib initiation
- description
- Real-world Progression-free survival (rwPFS) defined as the time from initiation of olaparib therapy (index date) until earliest record of disease progression determined by physician's assessment, or death. For any patient not known to have progressed or died, or who is lost to follow-up at the time of analysis, rwPFS will be right-censored based on the last recorded date on which the patient was known to be alive and progression-free.
- measure
- Time to first subsequent therapy (TFST)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
* Adult male patients (≥ 18 years old) * with metastatic castration-resistant prostate cancer, * who have initiated olaparib within at least, the last two months of study entry, at their physician's discretion or who have been enrolled in the funded early access program * who have been informed and are not opposed to their data collection --- For Patients initiated with olaparib in fEA, * Still alive and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician); * who deceased and who did not object to data collection for research purpose(s) during his or her lifetime. Exclusion criteria * Patients opposed to the collection of their data * Patients participating in a clinical trial with an investigational prostate cancer targeted drug within 30 days prior to Olaparib initiation
References
Publications (0)
Data not yet available