Metastatic Castration-resistant Prostate CancerPROWESsNCT06031805
PRostate Olaparib Real World Evidence Study
An observational study of Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 39 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- How many people
- 159 participants
- Where
- 39 sitesFrance
- Study dates
- 11 Oct 2023to 13 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
France39 sites
Research Site
Amiens
Research Site
Angers
Research Site
Antony
Research Site
Argenteuil
Research Site
Avignon
Research Site
Besançon
Research Site
Bordeaux
Research Site
Challes-les-Eaux
Research Site
Chambray-lès-Tours
Research Site
Clermont-Ferrand
Research Site
Compiègne
Research Site
Créteil
Research Site
Epagny METZ Tessy
Research Site
Ermont
Research Site
FORT de France
Research Site
Fréjus
Research Site
Grenoble
Research Site
Le Coudray
Research Site
Levallois-Perret
Research Site
Lyon
Research Site
Mantes-la-Jolie
Research Site
Morlaix
Research Site
Nancy
Research Site
Nantes
Research Site
Nice
Research Site
ORL ANS
Research Site
Paris
Research Site
Pointe à Pitre
Research Site
Poitiers
Research Site
Pontoise
Research Site
Rouen
Research Site
Saint-Etienne
Research Site
Saint-Grégoire
Research Site
Saint-Mandé
Research Site
Saint-Nazaire
Research Site
Strasbourg
Research Site
Tours
Research Site
Vannes
Research Site
Vantoux
About this study
Official title: 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
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 months from olaparib initiation
Secondary outcomes (28)
Real-world Progression-free survival (rwPFS)
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.
Measured: Up to 24 months from olaparib initiation
Time to first subsequent therapy (TFST)
Time to first subsequent therapy (TFST) defined as the time from initiation of olaparib therapy (index date) to the start of the first subsequent therapy or death, whichever is earlier. For any patient not known to have died and who has not started a subsequent treatment to olaparib at the end of follow-up, TFST will be right-censored at the last recorded day of follow up.
Measured: Up to 24 months from olaparib initiation
Real-world Progression-free survival 2 (rwPFS2)
Real-world Progression-free survival 2 (rwPFS2) defined as the time from initiation of olaparib therapy (index date) until earliest record of second disease progression determined by physician's assessment, or death. For any patient without second disease progression, and not known to have died at end of follow-up, rwPFS2 will be right-censored at the date of last follow up.
Measured: Up to 24 months from olaparib initiation
Time to second subsequent therapy (TSST)
Time to second subsequent therapy (TSST) defined as the time from initiation of olaparib therapy (index date) to the start of the second subsequent therapy or death, whichever is earlier. For any patient not known to have died and who have not started a second subsequent treatment to olaparib at the end of follow-up, TSST will be right-censored at the last recorded day of follow-up
Measured: Up to 24 months from olaparib initiation
Symptomatic skeletal related events free-survival (SSEFS)
Symptomatic skeletal related events free-survival (SSEFS) defined as the time from initiation of olaparib therapy (index date) until earliest record of symptomatic skeletal related events, or death. For any patient without symptomatic skeletal-related events not known to have died at the end of follow-up, SSEFS will be right-censored at the date of last follow-up.
Measured: Up to 24 months from olaparib initiation
Physician characteristics
Specialty, type of institution (public/private), region
Measured: At the end of enrollment period (Up to 32 months )
Patient socio-demographic characteristics
Ethnicity
Measured: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Weight
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Disease stage at tumor diagnosis
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Stage of tumor
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Localization of metastases
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Imaging modality
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time between all cancer stages (PC, mPC, mCRPC),
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Gleason score
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
PSA level
Measured: At the end of enrollment period (Up to 32 months )
Disease characteristics
Risk Criteria
Measured: At the end of enrollment period (Up to 32 months )
Treatment patterns description
- Systemic treatment, surgical intervention, radiotherapy, response to treatment,
Measured: At the end of enrollment period (Up to 32 months )
Treatment patterns description
- Previous, at baseline and subsequent treatment modalities
Measured: At the end of enrollment period (Up to 32 months )
BRCA testing characteristics and patterns description
Standard assessment
Measured: At the end of enrollment period (Up to 32 months )
Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes
- Clinical outcomes: as defined above
Measured: Up to 24 months from olaparib initiation
Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes
- Timing of BRCA testing
Measured: Up to 24 months from olaparib initiation
Reasons description for olaparib dosage changes, dose interruptions and treatment cessation
- Rate and reasons for olaparib dosage changes, dose interruptions, treatment cessation, or death
Measured: Up to 24 months from olaparib initiation
Patient socio-demographic characteristic
ECOG performance status
Measured: At the end of enrollment period (Up to 32 months )
Patient socio-demographic characteristics
Age
Measured: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Medical history and comorbidities of interest
Measured: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
G8 score
Measured: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Body mass index
Measured: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Height
Measured: At the end of enrollment period (Up to 32 months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start11 Oct 2023
- Primary completion13 Oct 2028 (estimated)
- Study completion13 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031805
- Sponsor's protocol ID
- D0817R00049
- Acronym
- PROWESs
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06031805
- Acronym / sponsor ID
- PROWESs / D0817R00049
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 159 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 13 Oct 2028 (estimated)
- Study completion
- 13 Oct 2028 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to treatment discontinuation (TTD)
Time frame: Up to 24 months from olaparib initiation
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
28 secondary outcomes
Real-world Progression-free survival (rwPFS)
Time frame: Up to 24 months from olaparib initiation
Time to first subsequent therapy (TFST)
Time frame: Up to 24 months from olaparib initiation
Real-world Progression-free survival 2 (rwPFS2)
Time frame: Up to 24 months from olaparib initiation
Time to second subsequent therapy (TSST)
Time frame: Up to 24 months from olaparib initiation
Symptomatic skeletal related events free-survival (SSEFS)
Time frame: Up to 24 months from olaparib initiation
Physician characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Patient socio-demographic characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Disease characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Treatment patterns description
Time frame: At the end of enrollment period (Up to 32 months )
Treatment patterns description
Time frame: At the end of enrollment period (Up to 32 months )
BRCA testing characteristics and patterns description
Time frame: At the end of enrollment period (Up to 32 months )
Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes
Time frame: Up to 24 months from olaparib initiation
Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes
Time frame: Up to 24 months from olaparib initiation
Reasons description for olaparib dosage changes, dose interruptions and treatment cessation
Time frame: Up to 24 months from olaparib initiation
Patient socio-demographic characteristic
Time frame: At the end of enrollment period (Up to 32 months )
Patient socio-demographic characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Patient clinical characteristics
Time frame: At the end of enrollment period (Up to 32 months )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 39 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment discontinuation (TTD) (time frame: Up to 24 months from olaparib initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.