Prostate Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate within the past 120 days

T1c-T2a, N0, M0
No bilateral disease

Prostate-specific antigen (PSA) no greater than 10 ng/mL

In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy
Gleason score no greater than 6
Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR
Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT

PATIENT CHARACTERISTICS:

Age:

75 and under

Performance status:

ECOG 0-2 OR
Zubrod 0-2

Renal:

Creatinine no greater than 3 mg/dL

Cardiovascular:

No significant cardiovascular disease
No New York Heart Association class III or IV heart disease

Other:

No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence
No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

See Disease Characteristics

At least 90 days since prior NHT

Duration of therapy no greater than 120 days
No concurrent NHT

Radiotherapy:

No prior radiotherapy to pelvis

Surgery:

No prior surgery for prostate cancer or benign disease, including:

Transurethral resection of the prostate
Transurethral resection of the bladder neck
Cryotherapy
Laser ablation
Microwave therapy

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

190

Study ID:

NCT00023686

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 36 Locations for this study

See Locations Near You

St. Vincent Cancer Center
Little Rock Arkansas, 72205, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94143, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62794, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Northeast Heights Cancer Center
Albuquerque New Mexico, 87109, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Wellspan Health - York Cancer Center
York Pennsylvania, 17403, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Wilford Hall Medical Center
Lackland Air Force Base Texas, 78236, United States
American Fork Hospital
American Fork Utah, 84003, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center
Saint George Utah, 84770, United States
LDS Hospital
Salt Lake City Utah, 84143, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington Vermont, 05401, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Veterans Affairs Medical Center - Richmond
Richmond Virginia, 23249, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
Vancouver General Hospital
Vancouver British Columbia, V5Z 3, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario, N6A 4, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Centre Hospitalier Universitaire de Quebec
Quebec City Quebec, G1R 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

190

Study ID:

NCT00023686

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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