Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.

Time frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.

Population: All eligible patients who did not withdraw consent

Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.

Time frame: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.

Population: All eligible patients who did not withdraw consent

Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

Time frame: From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.

Population: All eligible patients who have not withdrawn consent

Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0

Time frame: From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint

Population: Eligible patients with acute adverse event data who did not withdraw consent.

Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

Time frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.

Population: All eligible patients who have not withdrawn consent

Time frame: From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.

The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.

Time frame: Baseline and 12 months from randomization

Population: Eligible participants with baseline and 12 month SQLI

The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 (How often were you able to get an erection during sexual activity?) is scored from: none/almost never (response 0-1) or \< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.

Time frame: Twelve months from randomization

Population: Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline

Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.

Time frame: From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.

Population: All eligible patients who did not withdraw consent

Time frame: From randomization to 5 years.

Population: This analysis will not be done because we are unable to find the required algorithm for converting SQLI scores into utilities, which is needed for quality adjusted survival analysis.

Time frame: From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.