PRostate Olaparib Real World Evidence Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
Up to 24 months from olaparib initiationSecondary outcomes
1
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.
Time frame
Up to 24 months from olaparib initiation2
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.
Time frame
Up to 24 months from olaparib initiation3
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.
Time frame
Up to 24 months from olaparib initiation4
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
Time frame
Up to 24 months from olaparib initiationOther outcomes
1
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'
Time frame
From Olaparib initiation until date of death (Up to 24 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov