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

NCT06601205 | Completed Phase 2

• 3 other identifiers: 13CE20102003Italian League against CancerBerlucchi Foundation
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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 mg/day.

Conditions

Prostate Cancer; Prostatic Intraepithelial Neoplasia

Keywords

Prostate Cancer; Prostatic Intraepithelial Neoplasia; Chemoprevention; Flutamide; Finasteride; Biomarkers, drug response; Karyometry

Outcome Measures

Primary Outcomes (1)

• 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.

  4-6 weeks (baseline and at the end of the study biopsy)

Secondary Outcomes (7)

• Change of ki-67 value

  4-6 weeks (baseline and at the end of the study biopsy)

• Change Kariometry value

  4-6 weeks (baseline and at the end of the study biopsy)

• Serum biomarkers values

  4-6 weeks (on blood samples at baseline and the day before surgery)

• Adverse Events

  4-6 weeks (during the treatment)

• Recurrence-free survival

  up to 20 years

Study Arms (3)

Flutamide

EXPERIMENTAL

1 tablet 250 mg daily until the day before surgery

Drug: Flutamide

Finasteride

EXPERIMENTAL

1 tablet 5 mg daily until the day before surgery

Drug: Finasteride

Placebo

PLACEBO COMPARATOR

1 tablet daily until the day before surgery

Other: Placebo

Interventions

Flutamide DRUG

1 tablet daily until the day before surgery

Also known as: Arm A

Flutamide

Finasteride DRUG

1 tablet daily until the day before surgery

Also known as: Arm B

Finasteride

Placebo OTHER

1 tablet daily until the day before surgery

Also known as: Arm C

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \> 18 years
• Patients with a biopsy proven, clinically intracapsular PCa who are candidates to radical retropubic prostatectomy
• ECOG performance status ≤ 2
• Satisfactory hematological and biochemical functions:
• Platelets ≥100 x 10\^9/L
• AST and ALT in the normal range
• Able to understand and sign an informed consent

You may not qualify if:

• Previous hormone treatment during the 8 weeks before enrollment
• Neurologic and psychiatric diseases precluding patient participation in the study
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with the study procedures.

Sponsors & Collaborators

• Ente Ospedaliero Ospedali Galliera: lead
• Universita degli Studi di Genova: collaborator
• Cliniche Humanitas Gavazzeni: collaborator
• Università Politecnica delle Marche: collaborator
• European Institute of Oncology: collaborator
• University of Arizona: collaborator

Study Sites (1)

Medical Oncology Ente Ospedaliero Ospedali Galliera

Genova, Italy, 16128, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Intraepithelial Neoplasia

Interventions

Flutamide; Finasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Andrea De Censi, MD

  E.O. Ospedali Galliera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The drugs and placebo were purchased through the Galliera Hospital Pharmacy, encapsulated to preserve blinding, then packaged and labelled for the study under GMP.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology Division

Model Details: The study was a prospective, randomized, phase IIB, placebo controlled, double-blind, pre-surgical trial of Finasteride 5 mg day versus Flutamide 250 mg day versus placebo in men with PCa. Patients with a biopsy proven, clinically intracapsular prostate cancer who were candidate to radical retropubic prostatectomy were enrolled in four different institutions in Northern Italy. Different biopsy criteria according to each contributing centre were acceptable provided that a minimum of 8 cores were evaluable. Patients were randomized to receive either flutamide, 250 mg/day orally, or finasteride, 5 mg/day orally, or oral placebo in a double-blind manner beginning 4 to 6 weeks before surgery.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: September 19, 2024
• Study Start: January 1, 2004
• Primary Completion: March 20, 2008
• Study Completion: June 16, 2017
• Last Updated: September 19, 2024

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)