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Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

NCT00003645 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-04-28

Study results available
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Summary

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Conditions

Interventions

DRUG

Flutamide

10.8 mg intramuscularly once every 3 months for 12 months

DRUG

Leuprolide Acetate

50 mg tablet orally daily for 12 months

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • AstraZeneca

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Curtis A. Pettaway, MD · M.D. Anderson Cancer Center

  • Michael O. Koch, MD · Indiana University Melvin and Bren Simon Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-14
Primary Completion
2017-03-20
Completion
2017-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00003645 on ClinicalTrials.gov