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.
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.
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
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There are 36 Locations for this study
Little Rock Arkansas, 72205, United States
San Francisco California, 94143, United States
Washington District of Columbia, 20307, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Springfield Illinois, 62794, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
Albuquerque New Mexico, 87109, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
York Pennsylvania, 17403, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
American Fork Utah, 84003, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84143, United States
Burlington Vermont, 05401, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23249, United States
Seattle Washington, 98108, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98431, United States
Vancouver British Columbia, V5Z 3, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Quebec City Quebec, G1R 2, Canada
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