MedPath

Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Procedure: surgery
Radiation: radiation
Registration Number
NCT00023686
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
190
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
surgerysurgeryPatients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter.
radiationradiationPatients 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.
Primary Outcome Measures
NameTimeMethod
overall survivalUp to 10 years
Secondary Outcome Measures
NameTimeMethod
disease free survivalUp to 10 years

Trial Locations

Locations (36)

Wellspan Health - York Cancer Center

πŸ‡ΊπŸ‡Έ

York, Pennsylvania, United States

Winship Cancer Institute of Emory University

πŸ‡ΊπŸ‡Έ

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

Cleveland Clinic Taussig Cancer Center

πŸ‡ΊπŸ‡Έ

Cleveland, Ohio, United States

Veterans Affairs Medical Center - Seattle

πŸ‡ΊπŸ‡Έ

Seattle, Washington, United States

University of Texas - MD Anderson Cancer Center

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

University Cancer Center at University of Washington Medical Center

πŸ‡ΊπŸ‡Έ

Seattle, Washington, United States

Washington University School of Medicine

πŸ‡ΊπŸ‡Έ

Saint Louis, Missouri, United States

UCSF Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

San Francisco, California, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

πŸ‡ΊπŸ‡Έ

Nashville, Tennessee, United States

LDS Hospital

πŸ‡ΊπŸ‡Έ

Salt Lake City, Utah, United States

St. Vincent Cancer Center

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

Walter Reed Army Medical Center

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

πŸ‡ΊπŸ‡Έ

Tampa, Florida, United States

Southern Illinois University School of Medicine

πŸ‡ΊπŸ‡Έ

Springfield, Illinois, United States

Holden Comprehensive Cancer Center at University of Iowa

πŸ‡ΊπŸ‡Έ

Iowa City, Iowa, United States

Northeast Heights Cancer Center

πŸ‡ΊπŸ‡Έ

Albuquerque, New Mexico, United States

Kansas Cancer Institute at the University of Kansas Medical Center

πŸ‡ΊπŸ‡Έ

Kansas City, Kansas, United States

Memorial Sloan-Kettering Cancer Center

πŸ‡ΊπŸ‡Έ

New York, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

πŸ‡ΊπŸ‡Έ

Rochester, New York, United States

Comprehensive Cancer Center at Wake Forest University

πŸ‡ΊπŸ‡Έ

Winston-Salem, North Carolina, United States

American Fork Hospital

πŸ‡ΊπŸ‡Έ

American Fork, Utah, United States

Utah Valley Regional Medical Center - Provo

πŸ‡ΊπŸ‡Έ

Provo, Utah, United States

Wilford Hall Medical Center

πŸ‡ΊπŸ‡Έ

Lackland Air Force Base, Texas, United States

McKay-Dee Hospital Center

πŸ‡ΊπŸ‡Έ

Ogden, Utah, United States

Dixie Regional Medical Center

πŸ‡ΊπŸ‡Έ

Saint George, Utah, United States

Fletcher Allen Health Care - Medical Center Campus

πŸ‡ΊπŸ‡Έ

Burlington, Vermont, United States

Veterans Affairs Medical Center - Richmond

πŸ‡ΊπŸ‡Έ

Richmond, Virginia, United States

Sentara Norfolk General Hospital

πŸ‡ΊπŸ‡Έ

Norfolk, Virginia, United States

Madigan Army Medical Center

πŸ‡ΊπŸ‡Έ

Tacoma, Washington, United States

Margaret and Charles Juravinski Cancer Centre

πŸ‡¨πŸ‡¦

Hamilton, Ontario, Canada

Vancouver General Hospital

πŸ‡¨πŸ‡¦

Vancouver, British Columbia, Canada

Cancer Care Ontario-London Regional Cancer Centre

πŸ‡¨πŸ‡¦

London, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

πŸ‡¨πŸ‡¦

Toronto, Ontario, Canada

Princess Margaret Hospital

πŸ‡¨πŸ‡¦

Toronto, Ontario, Canada

Centre Hospitalier Universitaire de Quebec

πŸ‡¨πŸ‡¦

Quebec City, Quebec, Canada

Β© Copyright 2025. All Rights Reserved by MedPath