Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601205
Status:
COMPLETED
Last Update Posted:
None
First Post:
2019-02-12
Brief Title:
Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase IIB Double Blind Placebo Controlled Multicenter Pre-surgical Window-of-opportunity Trial of Finasteride Vs Low-dose Flutamide Vs Placebo in Prostate Cancer 2F Trial
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2F
Brief Summary:
Pre-surgical window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints Finasteride has been shown to reduce prostate cancer development in a large phase III trial and flutamide has a well-known anticancer effect in advanced prostate cancer at the dose of 750 mgday
Detailed Description:
In this randomized phase IIB double blind placebo controlled multicenter pre-surgical window-of-opportunity trial we compared the effects of finasteride 5 mgday versus low-dose flutamide 250 mgday or placebo on tissue biomarkers in patients with prostate cancer who were candidate to radical surgery Specifically the effects of both drugs on the change in epithelial cell nuclear area in prostate cancer tissue between pre- and post-treatment biopsies was evaluated primary endpoint Moreover the changes of the proliferation marker Ki-67 and of karyometric parameters in benign dysplastic HG-PIN and malignant tissues were evaluated secondary endpoints Additional endpoints include the changes of serum PSA and testosterone assessment of toxicity overall survival recurrence-free survival and event-free recurrence death survival Patients with intracapsular biopsy proven prostate cancer were randomized to either flutamide 250 mgday or finasteride 5 mgday or placebo for 4-6 weeks before radical prostatectomy Blood samples were taken before and after treatment At surgery end-of-study ex-vivo biopsies were obtained from the prostatectomy specimens to assess the treatment changes in nuclear area primary endpoint Ki-67 topoisomerase-II-α and a 20-feature karyometric discrimant function in normal high-grade PIN and malignant tissue After surgery patients were followed up for at least 15 years to assess recurrence andor mortality We also plan to follow-up patients by telephone interview to assess their vital status for up to 20 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None