Metastatic Castration-resistant Prostate Cancer
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment discontinuation (TTD) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Progression-free survival (rwPFS) | Up to 24 months from olaparib initiation | 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. |
| Time to first subsequent therapy (TFST) | Up to 24 months from olaparib initiation | 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. |
| Real-world Progression-free survival 2 (rwPFS2) | Up to 24 months from olaparib initiation | 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. |
| Time to second subsequent therapy (TSST) | Up to 24 months from olaparib initiation | 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 |
| Symptomatic skeletal related events free-survival (SSEFS) | Up to 24 months from olaparib initiation | 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. |
| Physician characteristics | At the end of enrollment period (Up to 32 months ) | Specialty, type of institution (public/private), region |
| Patient socio-demographic characteristics | At the end of enrollment period (Up to 32 months ) | Ethnicity |
| Patient clinical characteristics | At the end of enrollment period (Up to 32 months ) | Weight |
| Disease characteristics | At the end of enrollment period (Up to 32 months ) | Disease stage at tumor diagnosis |
| Treatment patterns description | At the end of enrollment period (Up to 32 months ) | o Systemic treatment, surgical intervention, radiotherapy, response to treatment, |
| BRCA testing characteristics and patterns description | At the end of enrollment period (Up to 32 months ) | Standard assessment |
| Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes | Up to 24 months from olaparib initiation | o Clinical outcomes: as defined above |
| Reasons description for olaparib dosage changes, dose interruptions and treatment cessation | Up to 24 months from olaparib initiation | o Rate and reasons for olaparib dosage changes, dose interruptions, treatment cessation, or death |
| Patient socio-demographic characteristic | At the end of enrollment period (Up to 32 months ) | ECOG performance status |
Countries
France
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed