Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorSanta Chiara Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
BRCA mutant Metastatic castration-resistant prostate cancer patients progressing after first-line ARPI who are treated with olaparib in clinical practice
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Olaparib
DrugOlaparib given according the clinical practice to BRCA positive mCRPC patients
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: mCRPC treated with olaparib1 intervention
Trial outcomes
Primary outcomes
1
disease control
projected survival from treatment start
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 monthsSecondary outcomes
1
biochemical response
rate of patients with PSA reduction \> 50%
Time frame
Through study completion, an average of 1 years2
response rate
rate of patients with measurable disease showing partial or complete response
Time frame
Through study completion, an average of 1 years3
PFS
projected survival without progression
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 months4
toxicity rate
toxicity recorded during the treatment
Time frame
Through study completion, an average of 1 yearsSponsors and contacts
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Source ClinicalTrials.gov