A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
OBJECTIVES:
- Compare overall survival in patients with stage II prostate cancer treated with radical
prostatectomy vs brachytherapy.
- Compare metastasis-free survival and probability of survival without symptoms of
patients treated with these regimens.
- Compare the side effects of these treatment regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radical prostatectomy.
- Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103
seeds Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for
this study within 5.5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Paul H. Lange, MD
Study Chair
University of Washington
United States: Federal Government
CDR0000068851
NCT00023686
October 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Wellspan Health - York Cancer Center | York, Pennsylvania 17403 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
American Fork Hospital | American Fork, Utah 84003 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
Kansas Cancer Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7357 |
Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
St. Vincent Cancer Center | Little Rock, Arkansas 72205-5499 |
Northeast Heights Cancer Center | Albuquerque, New Mexico 87109 |