PRostate Olaparib Real World Evidence Study

AstraZeneca300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

* 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

Locations (65)

Outcomes

Primary Outcomes

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 initiation

Secondary Outcomes

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 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.

Time frame: 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.

Time frame: Up to 24 months from olaparib initiation

Time to second subsequent therapy (TSST)

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Amiens, France

RECRUITING

Research Site

Angers, France

NOT_YET_RECRUITING

Research Site

Antony, France

RECRUITING

Research Site

Argenteuil, France

RECRUITING

Research Site

Avignon, France

RECRUITING

Research Site

Avignon, France

NOT_YET_RECRUITING

Research Site

Besançon, France

RECRUITING

Research Site

Bordeaux, France

NOT_YET_RECRUITING

Research Site

Bordeaux, France

RECRUITING

Research Site

Bordeaux, France

WITHDRAWN

...and 55 more locations

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 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.

Time frame: Up to 24 months from olaparib initiation

Physician characteristics

Specialty, type of institution (public/private), region

Time frame: At the end of enrollment period (Up to 32 months )

Patient socio-demographic characteristics

Ethnicity

Time frame: At the end of enrollment period (Up to 32 months )

Patient clinical characteristics

Weight

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Disease stage at tumor diagnosis

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Stage of tumor

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Localization of metastases

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Imaging modality

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Time between all cancer stages (PC, mPC, mCRPC),

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Gleason score

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

PSA level

Time frame: At the end of enrollment period (Up to 32 months )

Disease characteristics

Risk Criteria

Time frame: At the end of enrollment period (Up to 32 months )

Treatment patterns description

o Systemic treatment, surgical intervention, radiotherapy, response to treatment,

Time frame: At the end of enrollment period (Up to 32 months )

Treatment patterns description

o Previous, at baseline and subsequent treatment modalities

Time frame: At the end of enrollment period (Up to 32 months )

BRCA testing characteristics and patterns description

Standard assessment

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

o Clinical outcomes: as defined above

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

o Timing of BRCA testing

Time frame: 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

Time frame: Up to 24 months from olaparib initiation

Patient socio-demographic characteristic

ECOG performance status

Time frame: At the end of enrollment period (Up to 32 months )

Patient socio-demographic characteristics

Age

Time frame: At the end of enrollment period (Up to 32 months )

Patient clinical characteristics

Medical history and comorbidities of interest

Time frame: At the end of enrollment period (Up to 32 months )

Patient clinical characteristics

G8 score

Time frame: At the end of enrollment period (Up to 32 months )

Patient clinical characteristics

Body mass index

Time frame: At the end of enrollment period (Up to 32 months )

Patient clinical characteristics

Height

Time frame: At the end of enrollment period (Up to 32 months )