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

NCT ID: NCT06380738

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-14

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Castration-resistant Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Aschaffenburg, , Germany

Site Status RECRUITING

Research Site

Augsburg, , Germany

Site Status RECRUITING

Research Site

Bergisch Gladbach, , Germany

Site Status RECRUITING

Research Site

Berlin, , Germany

Site Status RECRUITING

Research Site

Bonn, , Germany

Site Status RECRUITING

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Cologne, , Germany

Site Status RECRUITING

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Dresden, , Germany

Site Status RECRUITING

Research Site

Duisburg, , Germany

Site Status RECRUITING

Research Site

Eisenach, , Germany

Site Status RECRUITING

Research Site

Eisleben Lutherstadt, , Germany

Site Status RECRUITING

Research Site

Frankfurt, , Germany

Site Status RECRUITING

Research Site

Greifswald, , Germany

Site Status RECRUITING

Research Site

Halle, , Germany

Site Status RECRUITING

Research Site

Hamburg, , Germany

Site Status RECRUITING

Research Site

Hanover, , Germany

Site Status RECRUITING

Research Site

Heidelberg, , Germany

Site Status RECRUITING

Research Site

Heinsberg, , Germany

Site Status RECRUITING

Research Site

Herzogenaurach, , Germany

Site Status RECRUITING

Research Site

Leipzig, , Germany

Site Status RECRUITING

Research Site

Lübeck, , Germany

Site Status RECRUITING

Research Site

Lüneburg, , Germany

Site Status RECRUITING

Research Site

Magdeburg, , Germany

Site Status RECRUITING

Research Site

Marburg, , Germany

Site Status RECRUITING

Research Site

Mülheim, , Germany

Site Status RECRUITING

Research Site

Münster, , Germany

Site Status RECRUITING

Research Site

Neunkirchen, , Germany

Site Status RECRUITING

Research Site

Nuremberg, , Germany

Site Status RECRUITING

Research Site

Rüsselsheim am Main, , Germany

Site Status RECRUITING

Research Site

Saalfeld, , Germany

Site Status RECRUITING

Research Site

Speyer, , Germany

Site Status RECRUITING

Research Site

Trier, , Germany

Site Status RECRUITING

Research Site

Tübingen, , Germany

Site Status RECRUITING

Research Site

Westerstede, , Germany

Site Status RECRUITING

Research Site

Wetzlar, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D0817R00074

Identifier Type: OTHER

Identifier Source: secondary_id

D0817R00074

Identifier Type: -

Identifier Source: org_study_id