A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Intermediate risk for disease relapse as determined by any of the following
combination of factors:

- T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10
but no greater than 100 ng/mL

- T1b-4, Gleason score 7, and PSA less than 20 ng/mL

- T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL

- Must have disease confirmation within 180 days of study randomization

- Clinically negative lymph nodes (N0) as established by imaging or negative lymph
nodes by nodal sampling or dissection

- Radiologic or radioimmunoscintigraphy findings suggestive of regional nodal
involvement allowed provided cytologic or histologic evaluation shows no
evidence of a neoplastic process

- Equivocal radiologic findings (i.e., maximum nodal size no greater than 1.5 cm)
allowed

- No distant metastases (M0)

- Radionuclide imaging findings suggestive but not diagnostic of metastatic
disease allowed provided radiologic imaging does not confirm metastatic disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0 or 1

Life expectancy:

- At least 10 years

Hematopoietic:

- Not specified

Hepatic:

- ALT no greater than 2 times upper limit of normal

Renal:

- Not specified

Other:

- Fertile patients must use effective contraception

- No other concurrent medical illness that would result in a life expectancy of less
than 10 years

- No other invasive malignancy within the past 5 years except localized basal cell or
squamous cell skin cancer

- No other concurrent major medical or psychiatric illness that would preclude study
treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for prostate cancer

Endocrine therapy:

- No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone
(LHRH) agonist AND bicalutamide OR flutamide provided:

- LHRH agonist was initiated no more than 30 days before study randomization and
bicalutamide OR flutamide was initiated no more than 14 days before or after
LHRH agonist administration

- No concurrent finasteride for prostatic hypertrophy

Radiotherapy:

- No prior pelvic external beam radiotherapy

- No prior radionuclide prostate brachytherapy

- No concurrent intensity-modulated radiotherapy

Surgery:

- No prior prostatectomy

- No prior prostatic cryosurgery

- No prior bilateral orchiectomy

Other:

- No other concurrent medical research study involving prostate cancer treatment