Treatment
All patients began treatment within 21 days after randomization. Radiotherapy, administered in daily 1.8-Gy fractions prescribed to the isocenter of the treatment volume, consisted of 46.8 Gy delivered to the pelvis (prostate and regional lymph nodes), followed by 19.8 Gy to the prostate, for a total dose of 66.6 Gy. Treatment of the regional lymph nodes was omitted in patients with negative lymph-node dissections or with a PSA level of less than 10 ng per milliliter and a Gleason score of less than 6. The study cochairs reviewed the simulation and portal films for each treatment field. Patients assigned to short-term ADT received flutamide at a dose of 250 mg orally three times a day and either monthly subcutaneous goserelin at a dose of 3.6 mg or intramuscular leuprolide at a dose of 7.5 mg for 4 months. Radiotherapy commenced after 2 months of androgen deprivation. Flutamide was discontinued if the level of alanine aminotransferase increased to more than twice the upper limit of the normal range.

Assessments
At the beginning and end of radiotherapy, assessments included a history taking and physical examination, performance status, complete blood count, and levels of alkaline phosphatase, alanine aminotransferase, PSA, and serum testosterone. Follow-up visits occurred at intervals of 3 months during the first year, 4 months during the second year, 6 months in years 3 through 5, and then annually. PSA values were obtained at each visit, along with the serum testosterone level and complete blood count during the first 2 years and the alkaline phosphatase level yearly. Repeat prostate biopsy 2 years after treatment was planned for patients without medical contraindications or evidence of local or distant disease and for patients who had not undergone orchiectomy or received hormonal treatment. Acute and late toxic effects were assessed with the use of the RTOG toxicity scales.

At each visit during the first 2 years, the first 793 patients enrolled in the study completed the Sexual Adjustment Questionnaire. Erectile dysfunction was assessed with the question, “When sexually excited, are you able to get an erection?” The five levels of response were: always or almost always, sometimes, almost never or never, did not try, and no answer.

End Points
All end points were measured from the date of randomization. Overall survival, the primary end point, was calculated at the date of death from any cause. Secondary end points included diseasespecific mortality, distant metastases, biochemical failure (an increasing level of PSA), and the rate of positive findings on repeat prostate biopsy at 2 years. Disease-specific mortality included all deaths from prostate cancer or treatment complications, as well as deaths from unknown causes in patients with either active cancer or a previously documented relapse. The study cochairs reviewed the reported causes of death, and complicated cases were reviewed by committee. The scoring of distant metastasis required documentation of metastatic disease. The Phoenix Consensus Conference definition (an increase in the PSA level of >2 ng per milliliter above the nadir) was used to define biochemical failure.