Clinical trial NCT06380738: Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)
Official title: A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-04-24
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Time to treatment discontinuation
timeFrame: Up to 12 months
Secondary outcomes:
measure: Time to first subsequent therapy
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bergisch Gladbach
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Eisenach
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Greifswald
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heinsberg
country: Germany
facility: Research Site
city: Herzogenaurach
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Luebeck
country: Germany
facility: Research Site
city: Luneburg
country: Germany
facility: Research Site
city: Lutherstadt Eisleben
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Muelheim
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Neunkirchen
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Ruesselsheim
country: Germany
facility: Research Site
city: Saalfeld
country: Germany
facility: Research Site
city: Speyer
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Westerstede
country: Germany
facility: Research Site
city: Wetzlar
country: Germany
facility: Research Site
Study officials:
References: