Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated

Status Terminated

Clinical Trial 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.

Clinical Trial Description

OBJECTIVES:

- Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression.

- Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival.

- Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels.

- Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition.

- Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

- Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.

- Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003645
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Terminated
Phase	Phase 3
Start date	June 14, 1999
Completion date	March 20, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms