Surgery Versus Internal Radiation in Treating Patients With Stage II 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.

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