PRostate Olaparib Real World Evidence Study

Официальное название

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

Обзор

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.

Первичные конечные точки

• Time to treatment discontinuation (TTD) [Срок оценки: Up to 24 months from olaparib initiation]

Вторичные конечные точки (12)

• Real-world Progression-free survival (rwPFS) [Срок оценки: Up to 24 months from olaparib initiation]
• Time to first subsequent therapy (TFST) [Срок оценки: Up to 24 months from olaparib initiation]
• Real-world Progression-free survival 2 (rwPFS2) [Срок оценки: Up to 24 months from olaparib initiation]
• Time to second subsequent therapy (TSST) [Срок оценки: Up to 24 months from olaparib initiation]
• Symptomatic skeletal related events free-survival (SSEFS) [Срок оценки: Up to 24 months from olaparib initiation]
• Physician characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]
• Patient socio-demographic characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]
• Patient clinical characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]
• Disease characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]
• Disease characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]
• Disease characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]
• Disease characteristics [Срок оценки: At the end of enrollment period (Up to 32 months )]

Критерии участия

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 65 центров

• Research Site — Amiens
• Research Site — Angers
• Research Site — Antony
• Research Site — Argenteuil
• Research Site — Avignon
• Research Site — Avignon
• Research Site — Besançon
• Research Site — Bordeaux
• … и ещё 57 центров

Идентификаторы

NCT: NCT06031805 · D0817R00049

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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