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NCT00438464 · ClinicalTrials.gov registry record · Phase 2

Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

A Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
204
Enrollment target
8
Study locations

NCT00438464 is a Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 204 participants, above the 100-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target (104% higher). The trial reports 8 study locations across 2 states.

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The verdict

NCT00438464, a Phase 2 study of Adenocarcinoma of the Prostate and Stage II Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
204 participants
Enrollment target
8
Study locations

Study Summary

This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions Studied

Adenocarcinoma of the Prostate Stage II Prostate Cancer

Interventions

  • OTHER Placebo
  • DRUG Finasteride
  • PROCEDURE Prostatectomy
  • OTHER Laboratory biomarker analysis

Study Locations (8)

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • M D Anderson Cancer Center - Houston
  • Audie L Murphy Veterans Affairs Hospital - San Antonio
  • Cancer Therapy and Research Center - San Antonio
  • University Hospital - San Antonio
  • University of Texas Health Science Center at San Antonio - San Antonio

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2007-02
Est. Completion 2012-04
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT00438464

The ClinicalTrials.gov registry entry for NCT00438464 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 100-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target (104% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Adenocarcinoma of the Prostate appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT00438464 reports 8 study locations spanning 2 distinct geographic areas - top geographies include Texas, Ohio.

Frequently Asked Questions

What is clinical trial NCT00438464 about?

NCT00438464 is a clinical study titled "Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery". This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testoster...

What is the current status of trial NCT00438464?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2007-02. Estimated completion is 2012-04.

What conditions does trial NCT00438464 study?

This clinical trial studies the following conditions: Adenocarcinoma of the Prostate, Stage II Prostate Cancer.

What interventions are being tested in trial NCT00438464?

The interventions under investigation include: Placebo (OTHER), Finasteride (DRUG), Prostatectomy (PROCEDURE), Laboratory biomarker analysis (OTHER).

Who is sponsoring clinical trial NCT00438464?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00438464 being conducted?

This trial has 8 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.