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

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.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Research Site, Aschaffenburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Time to treatment discontinuation

Time frame: Up to 12 months

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-exposed and NHA-naive), respectively.

TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.

Secondary outcomes

Time to first subsequent therapy

Time frame: Up to 24 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: PROceed

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Apr 24, 2024
Registry last updated: Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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