Androgen Suppression Plus Radiation Therapy in Treating Patients With

Status Completed

Clinical Trial Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.

Clinical Trial Description

OBJECTIVES:

- Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.

- Determine the safety of EBRT+BT in these patients.

- Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.

OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.

Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00006359
Study type	Interventional
Source	Alliance for Clinical Trials in Oncology
Contact
Status	Completed
Phase	Phase 2
Start date	September 2000
Completion date	March 2012

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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.

Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms