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COMPLETED Phase 2

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

NCT00438464 · View on ClinicalTrials.gov ↗

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.

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00438464

The ClinicalTrials.gov registry entry for NCT00438464 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00438464 reports 8 study locations spanning 2 distinct geographic areas — top geographies include Texas, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00438464?

The interventions under investigation include: Placebo (OTHER), Finasteride (DRUG), Prostatectomy (PROCEDURE), Laboratory biomarker analysis (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00438464?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial