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Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.

NCT06601205 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-09-19

No results posted yet for this study

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 mg/day.

Conditions

Interventions

DRUG

Flutamide

1 tablet 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

Sponsors & Collaborators

  • Universita degli Studi di Genova

    collaborator OTHER

  • Cliniche Humanitas Gavazzeni

    collaborator OTHER

  • Università Politecnica delle Marche

    collaborator OTHER

  • European Institute of Oncology

    collaborator OTHER

  • University of Arizona

    collaborator OTHER

  • Ente Ospedaliero Ospedali Galliera

    lead OTHER

Principal Investigators

  • Andrea De Censi, MD · E.O. Ospedali Galliera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-01
Primary Completion
2008-03-20
Completion
2017-06-16

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06601205 on ClinicalTrials.gov