BRCA Mutation, Castrate Resistant Prostate Cancer, Prostate Cancer
Conditions
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.
Interventions
DRUGOlaparib
Olaparib given according the clinical practice to BRCA positive mCRPC patients
Sponsors
Santa Chiara Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice
Exclusion criteria
Olaparib treatment in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease control | 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
| Measure | Time frame | Description |
|---|---|---|
| biochemical response | Through study completion, an average of 1 years | rate of patients with PSA reduction \> 50% |
| response rate | Through study completion, an average of 1 years | rate of patients with measurable disease showing partial or complete response |
| 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 | projected survival without progression |
| toxicity rate | Through study completion, an average of 1 years | toxicity recorded during the treatment |
Countries
Italy
Contacts
Primary ContactOrazio Caffo, MD
Outcome results
None listed