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NCT Number: NCT06783127

Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer BRCA Mutation Castrate Resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Sabrina Rossetti, Naples, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Olaparib treatment in a clinical trial

Treatment and study plan

Olaparib

Drug

Olaparib given according the clinical practice to BRCA positive mCRPC patients

Primary outcomes

  1. 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

Secondary outcomes

  1. biochemical response

    Time frame: Through study completion, an average of 1 years

    rate of patients with PSA reduction > 50%

  2. response rate

    Time frame: Through study completion, an average of 1 years

    rate of patients with measurable disease showing partial or complete response

  3. 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

  4. toxicity rate

    Time frame: Through study completion, an average of 1 years

    toxicity recorded during the treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Orazio Caffo, MD

CONTACT

[email protected]

+390461902478

Sponsors and collaborators

Lead sponsor

Santa Chiara Hospital

Other

Registry information

Official study title

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

Acronym: COROS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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