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

NCT00438464 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-03-09

Study results available
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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

  • Adenocarcinoma of the Prostate
  • Stage II Prostate Cancer

Interventions

DRUG

Finasteride

Given PO

OTHER

Placebo

Given PO

PROCEDURE

Prostatectomy

Undergo prostatectomy

OTHER

Laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jeri Kim · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00438464 on ClinicalTrials.gov