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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06031805
Other study ID # D0817R00049
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 11, 2023
Est. completion date October 13, 2028

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date October 13, 2028
Est. primary completion date October 13, 2028
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Research Site Amiens
France Research Site Angers Cedex 9
France Research Site Antony
France Research Site Argenteuil
France Research Site Avignon
France Research Site Besancon
France Research Site Bordeaux
France Research Site Challes Les Eaux
France Research Site Chambray Les Tours
France Research Site Chambray Les Tours
France Research Site Champigny Sur Marne
France Research Site Clermont-ferrand Cedex 1
France Research Site Compiegne Cedex
France Research Site Epagny METZ Tessy
France Research Site Epagny METZ Tessy
France Research Site FORT DE France
France Research Site Frejus Cedex
France Research Site Frejus Cedex
France Research Site Le Chesnay
France Research Site Le Coudray
France Research Site Le Coudray
France Research Site Le Mans
France Research Site Levallois Perret
France Research Site Lyon
France Research Site Lyon Cedex 09
France Research Site Mantes La Jolie
France Research Site Marseille
France Research Site Morlaix
France Research Site Nancy
France Research Site Nancy
France Research Site Nantes
France Research Site Nice Cedex 2
France Research Site Nice Cedex 2
France Research Site Orléans
France Research Site Orléans
France Research Site Paris
France Research Site Pointe A Pitre
France Research Site Pontoise
France Research Site Quint Fonsegrives
France Research Site Rouen
France Research Site Saint Denis- LA Reunion
France Research Site Saint Doulchard
France Research Site Saint Mande
France Research Site Saint-etienne
France Research Site Saint-etienne
France Research Site Saint-etienne Cedex 1
France Research Site Saint-gregoire
France Research Site St Nazaire
France Research Site Tours
France Research Site Tours
France Research Site Vannes
France Research Site Vantoux

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 36 months from olaparib initiation
See also
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