Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00002889
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy.

PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.

Detailed Description

OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.

OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.

PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.

Study Timeline

• Study Start: 1997-05
• Study First Submitted: 1999-11-01
• Primary Completion: 2004-01
• Study First Submitted QC: 2004-04-21
• Study First Posted: 2004-04-22
• Study Completion: 2009-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy	2 years post tx

Trial Locations

Locations (12)

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Joint Center for Radiation Therapy; 🇺🇸 Boston, Massachusetts, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Paterson, New Jersey, United States

Arthur G. James Cancer Hospital - Ohio State University; 🇺🇸 Columbus, Ohio, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States