Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
Overview
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.
Primary outcome measures
- Time to treatment discontinuation [Time frame: Up to 12 months]
Secondary outcome measures (1)
- Time to first subsequent therapy [Time frame: Up to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 34 centers
- Research Site — Aschaffenburg
- Research Site — Augsburg
- Research Site — Bergisch Gladbach
- Research Site — Berlin
- Research Site — Bonn
- Research Site — Cologne
- Research Site — Dresden
- Research Site — Duisburg
- … and 26 more centers
Identifiers
NCT: NCT06380738 · D0817R00074 · D0817R00074