Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)
PROceed
A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
1 other identifier
observational
250
1 country
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedStudy Start
First participant enrolled
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
December 26, 2025
December 1, 2025
3 years
February 1, 2024
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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-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.
Up to 12 months
Secondary Outcomes (1)
Time to first subsequent therapy
Up to 24 months
Eligibility Criteria
The study population will consist of patients with a confirmed mCRPC diagnosis that has initiated the combination of olaparib and abiraterone through routine clinical practice at participating sites in Germany.
You may qualify if:
- Willing and able to provide written informed consent;
- years of age and above;
- Documented histopathology or cytopathology of PCa, adenocarcinoma;
- Confirmed as mCRPC;
- Initiated olaparib + abiraterone after site activation
You may not qualify if:
- Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (34)
Research Site
Aschaffenburg, Germany
Research Site
Augsburg, Germany
Research Site
Bergisch Gladbach, Germany
Research Site
Berlin, Germany
Research Site
Bonn, Germany
Research Site
Cologne, Germany
Research Site
Dresden, Germany
Research Site
Duisburg, Germany
Research Site
Eisenach, Germany
Research Site
Eisleben Lutherstadt, Germany
Research Site
Frankfurt, Germany
Research Site
Greifswald, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Research Site
Hanover, Germany
Research Site
Heidelberg, Germany
Research Site
Heinsberg, Germany
Research Site
Herzogenaurach, Germany
Research Site
Leipzig, Germany
Research Site
Lübeck, Germany
Research Site
Lüneburg, Germany
Research Site
Magdeburg, Germany
Research Site
Marburg, Germany
Research Site
Mülheim, Germany
Research Site
Münster, Germany
Research Site
Neunkirchen, Germany
Research Site
Nuremberg, Germany
Research Site
Rüsselsheim am Main, Germany
Research Site
Saalfeld, Germany
Research Site
Speyer, Germany
Research Site
Trier, Germany
Research Site
Tübingen, Germany
Research Site
Westerstede, Germany
Research Site
Wetzlar, Germany
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2024
First Posted
April 24, 2024
Study Start
February 14, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.