Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: LHRH agonist; Drug: antiandrogen; Radiation: radiation therapy; Radiation: Brachytherapy boost

• Registration Number: NCT00006359
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed 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 Timeline

• Study Start: 2000-09
• Study First Submitted: 2000-10-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-10
• Study Completion: 2012-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Androgen suppression + EBRT + Brachytherapy	radiation therapy	Androgen suppression with external beam radiation therapy followed by brachytherapy boost
Androgen suppression + EBRT + Brachytherapy	Brachytherapy boost	Androgen suppression with external beam radiation therapy followed by brachytherapy boost
Androgen suppression + EBRT + Brachytherapy	LHRH agonist	Androgen suppression with external beam radiation therapy followed by brachytherapy boost
Androgen suppression + EBRT + Brachytherapy	antiandrogen	Androgen suppression with external beam radiation therapy followed by brachytherapy boost

Primary Outcome Measures

Name	Time	Method
Toxicity	q 3 mon for 2 yrs post tx initiation

Secondary Outcome Measures

Name	Time	Method
Time to PSA failure	6 years
Survival	6 years	Progression free and overall survival will be assessed

Trial Locations

Locations (26)

Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

St. Francis Hospital; 🇺🇸 Wilmington, Delaware, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando; 🇺🇸 Orlando, Florida, United States

Union Hospital Cancer Center at Union Hospital; 🇺🇸 Elkton MD, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Hudner Oncology Center at Saint Anne's Hospital; 🇺🇸 Fall River, Massachusetts, United States

UMASS Memorial Cancer Center - University Campus; 🇺🇸 Worcester, Massachusetts, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia; 🇺🇸 Columbia, Missouri, United States

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