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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (OS) defined as the time from olaparib initiation date to death. For any patient not known to have died at the end of follow-up or who is lost to follow-up at the time of analysis, OS will be right-censored based on the last recorded date on which the patient was known to be alive.é' | From Olaparib initiation until date of death (Up to 24 months) |
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,
Exclusion criteria
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Amiens | France | |||
| Research Site |
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| 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. | 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. | 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 | 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. | Up to 24 months from olaparib initiation |
| Physician characteristics | Specialty, type of institution (public/private), region | At the end of enrollment period (Up to 32 months ) |
| Patient socio-demographic characteristics | Ethnicity | At the end of enrollment period (Up to 32 months ) |
| Patient clinical characteristics | Weight | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Disease stage at tumor diagnosis | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Stage of tumor | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Localization of metastases | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Imaging modality | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Time between all cancer stages (PC, mPC, mCRPC), | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Gleason score | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | PSA level | At the end of enrollment period (Up to 32 months ) |
| Disease characteristics | Risk Criteria | At the end of enrollment period (Up to 32 months ) |
| Treatment patterns description | o Systemic treatment, surgical intervention, radiotherapy, response to treatment, | At the end of enrollment period (Up to 32 months ) |
| Treatment patterns description | o Previous, at baseline and subsequent treatment modalities | At the end of enrollment period (Up to 32 months ) |
| BRCA testing characteristics and patterns description | Standard assessment | 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 | o Clinical outcomes: as defined above | Up to 24 months from olaparib initiation |
| Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes | o Timing of BRCA testing | Up to 24 months from olaparib initiation |
| Reasons description for olaparib dosage changes, dose interruptions and treatment cessation | o Rate and reasons for olaparib dosage changes, dose interruptions, treatment cessation, or death | Up to 24 months from olaparib initiation |
| Patient socio-demographic characteristic | ECOG performance status | At the end of enrollment period (Up to 32 months ) |
| Patient socio-demographic characteristics | Age | At the end of enrollment period (Up to 32 months ) |
| Patient clinical characteristics | Medical history and comorbidities of interest | At the end of enrollment period (Up to 32 months ) |
| Patient clinical characteristics | G8 score | At the end of enrollment period (Up to 32 months ) |
| Patient clinical characteristics | Body mass index | At the end of enrollment period (Up to 32 months ) |
| Patient clinical characteristics | Height | At the end of enrollment period (Up to 32 months ) |
| Not yet recruiting |
| Angers |
| France |
| Research Site | Recruiting | Antony | France |
| Research Site | Recruiting | Argenteuil | France |
| Research Site | Recruiting | Avignon | France |
| Research Site | Not yet recruiting | Avignon | France |
| Research Site | Recruiting | Besançon | France |
| Research Site | Not yet recruiting | Bordeaux | France |
| Research Site | Recruiting | Bordeaux | France |
| Research Site | Withdrawn | Bordeaux | France |
| Research Site | Recruiting | Challes-les-Eaux | France |
| Research Site | Recruiting | Chambray-lès-Tours | France |
| Research Site | Not yet recruiting | Chambray-lès-Tours | France |
| Research Site | Not yet recruiting | Champigny-sur-Marne | France |
| Research Site | Recruiting | Clermont-Ferrand | France |
| Research Site | Not yet recruiting | Clermont-Ferrand | France |
| Research Site | Recruiting | Compiègne | France |
| Research Site | Recruiting | Créteil | France |
| Research Site | Recruiting | Epagny METZ Tessy | France |
| Research Site | Not yet recruiting | Epagny METZ Tessy | France |
| Research Site | Recruiting | Ermont | France |
| Research Site | Recruiting | FORT de France | France |
| Research Site | Recruiting | Fréjus | France |
| Research Site | Not yet recruiting | Fréjus | France |
| Research Site | Recruiting | Grenoble | France |
| Research Site | Not yet recruiting | Le Chesnay | France |
| Research Site | Recruiting | Le Coudray | France |
| Research Site | Not yet recruiting | Le Coudray | France |
| Research Site | Not yet recruiting | Le Mans | France |
| Research Site | Recruiting | Levallois-Perret | France |
| Research Site | Recruiting | Lyon | France |
| Research Site | Not yet recruiting | Lyon | France |
| Research Site | Recruiting | Mantes-la-Jolie | France |
| Research Site | Not yet recruiting | Mantes-la-Jolie | France |
| Research Site | Not yet recruiting | Marseille | France |
| Research Site | Not yet recruiting | Morlaix | France |
| Research Site | Recruiting | Nancy | France |
| Research Site | Not yet recruiting | Nancy | France |
| Research Site | Recruiting | Nantes | France |
| Research Site | Recruiting | Nice | France |
| Research Site | Recruiting | ORL ANS | France |
| Research Site | Recruiting | Paris | France |
| Research Site | Not yet recruiting | Paris | France |
| Research Site | Recruiting | Pointe à Pitre | France |
| Research Site | Recruiting | Poitiers | France |
| Research Site | Recruiting | Pontoise | France |
| Research Site | Not yet recruiting | Quint-Fonsegrives | France |
| Research Site | Recruiting | Rouen | France |
| Research Site | Not yet recruiting | Rouen | France |
| Research Site | Not yet recruiting | Saint Denis- LA Reunion | France |
| Research Site | Not yet recruiting | Saint-Doulchard | France |
| Research Site | Recruiting | Saint-Etienne | France |
| Research Site | Not yet recruiting | Saint-Etienne | France |
| Research Site | Recruiting | Saint-Grégoire | France |
| Research Site | Withdrawn | Saint-Grégoire | France |
| Research Site | Recruiting | Saint-Mandé | France |
| Research Site | Recruiting | Saint-Nazaire | France |
| Research Site | Not yet recruiting | Saint-Nazaire | France |
| Research Site | Recruiting | Strasbourg | France |
| Research Site | Not yet recruiting | Suresnes | France |
| Research Site | Recruiting | Tours | France |
| Research Site | Not yet recruiting | Vannes | France |
| Research Site | Recruiting | Vannes | France |
| Research Site | Recruiting | Vantoux | France |
| Research Site | Not yet recruiting | Vantoux | France |