NCT06783127

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2023Dec 2026

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

January 14, 2025

Last Update Submit

February 7, 2025

Conditions

Prostate CancerCastrate Resistant Prostate CancerBRCA Mutation

Outcome Measures

Primary Outcomes (1)

  • disease control

    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 Outcomes (4)

  • biochemical response

    Through study completion, an average of 1 years

  • response rate

    Through study completion, an average of 1 years

  • PFS

    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

    Through study completion, an average of 1 years

Study Arms (1)

mCRPC treated with olaparib

mCRPC patients who receive olaparib in daily clinical practice

Drug: Olaparib

Interventions

OlaparibDRUG

Olaparib given according the clinical practice to BRCA positive mCRPC patients

mCRPC treated with olaparib

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Olaparib treatment in a clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sabrina Rossetti

Napoli, Italy

RECRUITING

Orazio Caffo

Trento, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Orazio Caffo, MD

CONTACT

+390461902478orazio.caffo@apss.tn.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations

IT(2)