Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)

Metastatic Castration-resistant Prostate Cancer Clinical Trial

— PROceed  

Official title:

A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380738
• Other study ID #: D0817R00074
• Secondary ID: D0817R00074
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

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