PRostate Olaparib Real World Evidence Study
PROWESs
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
1 other identifier
observational
300
1 country
65
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2023
CompletedFirst Posted
Study publicly available on registry
September 11, 2023
CompletedStudy Start
First participant enrolled
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 13, 2028
April 27, 2026
April 1, 2026
5 years
September 4, 2023
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to treatment discontinuation (TTD)
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
Up to 24 months from olaparib initiation
Secondary Outcomes (28)
Real-world Progression-free survival (rwPFS)
Up to 24 months from olaparib initiation
Time to first subsequent therapy (TFST)
Up to 24 months from olaparib initiation
Real-world Progression-free survival 2 (rwPFS2)
Up to 24 months from olaparib initiation
Time to second subsequent therapy (TSST)
Up to 24 months from olaparib initiation
Symptomatic skeletal related events free-survival (SSEFS)
Up to 24 months from olaparib initiation
- +23 more secondary outcomes
Other Outcomes (1)
Overall survival (OS)
From Olaparib initiation until date of death (Up to 24 months)
Eligibility Criteria
Adult male patients 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 A sample of approximately 300 patients is expected to be enrolled from around 60 french sites.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (65)
Research Site
Amiens, France
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Angers, France
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Antony, France
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Argenteuil, France
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Avignon, France
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Avignon, France
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Besançon, France
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Bordeaux, France
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Bordeaux, France
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Challes-les-Eaux, France
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Chambray-lès-Tours, France
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Chambray-lès-Tours, France
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Champigny-sur-Marne, France
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Clermont-Ferrand, France
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Clermont-Ferrand, France
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Compiègne, France
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Créteil, France
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Créteil, France
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Epagny METZ Tessy, France
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Epagny METZ Tessy, France
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Ermont, France
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FORT de France, France
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Fréjus, France
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Fréjus, France
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Grenoble, France
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Le Chesnay, France
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Le Coudray, France
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Le Coudray, France
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Le Mans, France
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Levallois-Perret, France
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Lyon, France
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Lyon, France
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Mantes-la-Jolie, France
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Mantes-la-Jolie, France
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Marseille, France
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Morlaix, France
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Nancy, France
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Nancy, France
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Nantes, France
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Nice, France
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ORL ANS, France
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Paris, France
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Paris, France
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Pointe à Pitre, France
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Poitiers, France
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Pontoise, France
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Quint-Fonsegrives, France
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Rouen, France
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Rouen, France
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Saint Denis- LA Reunion, France
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Saint-Doulchard, France
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Saint-Etienne, France
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Saint-Etienne, France
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Saint-Grégoire, France
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Saint-Grégoire, France
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Saint-Mandé, France
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Saint-Nazaire, France
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Saint-Nazaire, France
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Strasbourg, France
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Suresnes, France
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Tours, France
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Tours, France
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Vannes, France
Research Site
Vantoux, France
Research Site
Vantoux, France
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2023
First Posted
September 11, 2023
Study Start
October 11, 2023
Primary Completion (Estimated)
October 13, 2028
Study Completion (Estimated)
October 13, 2028
Last Updated
April 27, 2026
Record last verified: 2026-04