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

December 19, 2025 updated by: AstraZeneca

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Aschaffenburg, Germany
        • Recruiting
        • Research Site
      • Augsburg, Germany
        • Recruiting
        • Research Site
      • Bergisch Gladbach, Germany
        • Recruiting
        • Research Site
      • Berlin, Germany
        • Recruiting
        • Research Site
      • Bonn, Germany
        • Recruiting
        • Research Site
      • Cologne, Germany
        • Recruiting
        • Research Site
      • Dresden, Germany
        • Recruiting
        • Research Site
      • Duisburg, Germany
        • Recruiting
        • Research Site
      • Eisenach, Germany
        • Recruiting
        • Research Site
      • Eisleben Lutherstadt, Germany
        • Recruiting
        • Research Site
      • Frankfurt, Germany
        • Recruiting
        • Research Site
      • Greifswald, Germany
        • Recruiting
        • Research Site
      • Halle, Germany
        • Recruiting
        • Research Site
      • Hamburg, Germany
        • Recruiting
        • Research Site
      • Hanover, Germany
        • Recruiting
        • Research Site
      • Heidelberg, Germany
        • Recruiting
        • Research Site
      • Heinsberg, Germany
        • Recruiting
        • Research Site
      • Herzogenaurach, Germany
        • Recruiting
        • Research Site
      • Leipzig, Germany
        • Recruiting
        • Research Site
      • Lübeck, Germany
        • Recruiting
        • Research Site
      • Lüneburg, Germany
        • Recruiting
        • Research Site
      • Magdeburg, Germany
        • Recruiting
        • Research Site
      • Marburg, Germany
        • Recruiting
        • Research Site
      • Mülheim, Germany
        • Recruiting
        • Research Site
      • Münster, Germany
        • Recruiting
        • Research Site
      • Neunkirchen, Germany
        • Recruiting
        • Research Site
      • Nuremberg, Germany
        • Recruiting
        • Research Site
      • Rüsselsheim am Main, Germany
        • Recruiting
        • Research Site
      • Saalfeld, Germany
        • Recruiting
        • Research Site
      • Speyer, Germany
        • Recruiting
        • Research Site
      • Trier, Germany
        • Recruiting
        • Research Site
      • Tübingen, Germany
        • Recruiting
        • Research Site
      • Westerstede, Germany
        • Recruiting
        • Research Site
      • Wetzlar, Germany
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0817R00074 (Other Identifier: AstraZeneca)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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