Clinical trial NCT06031805: PRostate Olaparib Real World Evidence Study
Official title: a French Observational Prospective Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male patients with metastatic castration-resistant prostate cancer who have initiated olaparib or for whom the decision to be treated with olaparib has been made by their physician.

A sample of approximately 300 patients is expected to be enrolled from around 60 french sites.

Brief summary: This French non-interventional prospective 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: Inclusion Criteria:

* Adult male patients (≥ 18 years old)
* With metastatic castration-resistant prostate cancer - Who have initiated olaparib within the last two months of study entry, or for whom the decision to be treated with olaparib has been made by their physician
* Who have been informed and are not opposed to this data collection

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

Primary outcomes:
measure: Time to treatment discontinuation (TTD)
timeFrame: Up to 36 months from olaparib initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Research Site
city: Angers Cedex 9
country: France
facility: Research Site
city: Antony
country: France
facility: Research Site
city: Argenteuil
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Challes Les Eaux
country: France
facility: Research Site
city: Chambray Les Tours
country: France
facility: Research Site
city: Chambray Les Tours
country: France
facility: Research Site
city: Champigny Sur Marne
country: France
facility: Research Site
city: Clermont-ferrand Cedex 1
country: France
facility: Research Site
city: Clermont-ferrand Cedex 1
country: France
facility: Research Site
city: Compiegne Cedex
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Epagny METZ Tessy
country: France
facility: Research Site
city: Epagny METZ Tessy
country: France
facility: Research Site
city: Ermont
country: France
facility: Research Site
city: FORT DE France
country: France
facility: Research Site
city: Frejus Cedex
country: France
facility: Research Site
city: Frejus Cedex
country: France
facility: Research Site
city: Grenoble Cedex 9
country: France
facility: Research Site
city: Le Chesnay
country: France
facility: Research Site
city: Le Coudray
country: France
facility: Research Site
city: Le Coudray
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Levallois Perret
country: France
facility: Research Site
city: Lyon Cedex 09
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Mantes La Jolie
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Morlaix
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Nice Cedex 2
country: France
facility: Research Site
city: Orl Ans
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pointe A Pitre
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Quint Fonsegrives
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saint Denis- LA Reunion
country: France
facility: Research Site
city: Saint Doulchard
country: France
facility: Research Site
city: Saint Mande
country: France
facility: Research Site
city: Saint-etienne Cedex 1
country: France
facility: Research Site
city: Saint-etienne
country: France
facility: Research Site
city: Saint-etienne
country: France
facility: Research Site
city: Saint-gregoire
country: France
facility: Research Site
city: Saint-gregoire
country: France
facility: Research Site
city: St Nazaire
country: France
facility: Research Site
city: St Nazaire
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Vannes
country: France
facility: Research Site
city: Vantoux
country: France
facility: Research Site
city: Vantoux
country: France
facility: Research Site
Study officials:
References: