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Keep this study
Lead
Alliance for Clinical Trials in Oncology
With
National Cancer Institute (NCI)
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.
Age
0–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
