A Phase 2/3 interventional study of Flutamide and Finasteride in Prostate Cancer and Prostatic Intraepithelial Neoplasia, sponsored by Ente Ospedaliero Ospedali Galliera. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ente Ospedaliero Ospedali Galliera · Phase 2/3, Interventional, and Prevention
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 mg/day.
In this randomized, phase IIB, double blind, placebo controlled, multicenter, pre-surgical, window-of-opportunity trial we compared the effects of finasteride (5 mg/day) versus low-dose flutamide (250 mg/day) 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 mg/day, or finasteride, 5 mg/day, 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 and/or mortality. We also plan to follow-up patients by telephone interview to assess their vital status for up to 20 years.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 125 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Ente Ospedaliero Ospedali Galliera is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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Satisfactory hematological and biochemical functions:
Exclusion Criteria:
1 tablet 250 mg daily until the day before surgery
Drug: Flutamide
1 tablet 5 mg daily until the day before surgery
Drug: Finasteride
1 tablet daily until the day before surgery
Other: Placebo
1 tablet daily until the day before surgery
Also known as: Arm A
1 tablet daily until the day before surgery
Also known as: Arm B
1 tablet daily until the day before surgery
Also known as: Arm C
Change of Nuclear area size
The study primary endpoint is the change of epithelial cell nuclear area in prostate cancer tissue and HG-PIN tissue between pre- and post-treatment measure in the two active treatment arms (Finasteride or Flutamide) compared with the placebo arm.
Time frame: 4-6 weeks (baseline and at the end of the study biopsy)
Change of ki-67 value
Changes of Ki-67 labeling index in normal, HG-PIN and prostate cancer cells in the three arms.
Time frame: 4-6 weeks (baseline and at the end of the study biopsy)
Change Kariometry value
Changes in karyometric features in normal HG-PIN and prostate cancer cells in the three arms.
Time frame: 4-6 weeks (baseline and at the end of the study biopsy)
Serum biomarkers values
Changes in total PSA, free PSA and testosterone concentrations after treatment in the three arms.
Time frame: 4-6 weeks (on blood samples at baseline and the day before surgery)
Adverse Events
Toxicity is assessed using the National Cancer Institute-Common Terminology Criteria for Adverse Events (version 3, 2003).
Time frame: 4-6 weeks (during the treatment)
Recurrence-free survival
Comparison of Recurrence-free survival among arms will be assessed by the Kaplan Meier actuarial survival curves and analyzed by the log-rank test and the Cox proportional hazard model for multivariate analyses. Vital status and medical condition will be assessed by telephone interview and clinical visit.
Time frame: up to 20 years
Comparison of Event free survival
Comparison of Event free survival among arms will be assessed by the Kaplan Meier actuarial survival curves and analyzed by the log-rank test and the Cox proportional hazard model for multivariate analyses. Vital status and medical condition will be assessed by telephone interview and clinical visit.
Time frame: up to 20 years
Comparison of Overall Survival
Comparison of Overall Survival among arms will be assessed by the Kaplan Meier actuarial survival curves and analyzed by the log-rank test and the Cox proportional hazard model for multivariate analyses. Vital status and medical condition will be assessed by telephone interview and clinical visit.
Time frame: up to 20 years
Plan to share: No
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Ran from Jan 2004 to primary completion in Mar 2008, 50 months.
Of 42 phase 2/3 interventional studies under Prostatic Neoplasms, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 39. This study's 50 months is below that.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Flutamide · Finasteride
Ente Ospedaliero Ospedali Galliera