Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer (COROS)

February 7, 2025 updated by: Orazio Caffo, Santa Chiara Hospital

Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer: An Observational Study

This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

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

  • Italy
      • Napoli, Italy
        • Recruiting
        • Sabrina Rossetti
        • Contact:
          • Sabrina Rossetti
      • Trento, Italy
        • Recruiting
        • Orazio Caffo
        • Contact:
          • Orazio Caffo

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

BRCA mutant Metastatic castration-resistant prostate cancer patients progressing after first-line ARPI who are treated with olaparib in clinical practice

Description

Inclusion Criteria:

BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice

Exclusion Criteria:

Olaparib treatment in a clinical trial

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mCRPC treated with olaparib
mCRPC patients who receive olaparib in daily clinical practice
Drug: Olaparib
Olaparib given according the clinical practice to BRCA positive mCRPC patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control
Time Frame: From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months
projected survival from treatment start
From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical response
Time Frame: Through study completion, an average of 1 years
rate of patients with PSA reduction > 50%
Through study completion, an average of 1 years
response rate
Time Frame: Through study completion, an average of 1 years
rate of patients with measurable disease showing partial or complete response
Through study completion, an average of 1 years
PFS
Time Frame: From the date of treatment start until the date of first progression or date of death from any cause, whichever came first, assessed up to 120 months
projected survival without progression
From the date of treatment start until the date of first progression or date of death from any cause, whichever came first, assessed up to 120 months
toxicity rate
Time Frame: Through study completion, an average of 1 years
toxicity recorded during the treatment
Through study completion, an average of 1 years

Collaborators and Investigators

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

Sponsor

Santa Chiara Hospital

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)

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A809

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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