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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06380738
Other study ID # D0817R00074
Secondary ID D0817R00074
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2024
Est. completion date January 31, 2027

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

PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date January 31, 2027
Est. primary completion date January 31, 2027
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - Willing and able to provide written informed consent; - 18 years of age and above; - Documented histopathology or cytopathology of PCa, adenocarcinoma; - Confirmed as mCRPC; - Initiated olaparib + abiraterone after site activation Exclusion Criteria: - Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Research Site Aschaffenburg
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Duisburg
Germany Research Site Franckfurt
Germany Research Site Halle
Germany Research Site Herzogenaurach
Germany Research Site Leipzig
Germany Research Site Lueneburg
Germany Research Site Muhlheim
Germany Research Site Nurnberg
Germany Research Site Russelsheim
Germany Research Site Speyer
Germany Research Site Wetzlar

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to treatment discontinuation Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-naive and NHA-exposed), respectively.
TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.
Up to 12 months
Secondary Time to first subsequent therapy Time to first subsequent therapy (TFST) in mCRPC patients treated with olaparib + abiraterone.
TFST is defined as the time from olaparib initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation or death due to any cause.
Up to 24 months
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