Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer

PRIMARY OBJECTIVES:

I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT
fractionation schedule without experiencing a treatment limiting toxicity.

SECONDARY OBJECTIVES:

I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical
failure-free survival.

OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5
days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or
long-term androgen deprivation therapy for up to 36 months. After completion of study
treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months for
2 years, and then annually until year 5.

Inclusion Criteria:

- Patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol
enrollment when the following criteria are met; patients must have low, intermediate
or high-risk adenocarcinoma of the prostate, as defined by the National Comprehensive
Cancer Network (NCCN) criteria

- A diagnostic CT scan of the abdomen and pelvis will be obtained to rule out regional
disease (maximum of 60 days prior to registration) for high-risk patients only

- A bone scan showing no evidence of metastatic disease is also required for patients
whose prostate-specific antigen (PSA) is greater than 20 ng/ml, Gleason's sum is
greater than 7, or T-stage is greater than T2b

- Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all
patients beginning hormone therapy

- AST within 1.5 x ULN is required for all patients beginning hormone therapy

- Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy

- Karnofsky Performance score >= 80

- Prior to registration, patients having received no more than three months treatment
with anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a
combination of the two remain eligible for protocol treatment; the qualifying PSA for
these patients will be the value recorded prior to the initiation of the hormone
therapy

Exclusion Criteria:

- Patients with history of inflammatory bowel disease, or who require steroid or
cytotoxic therapy for collagen vascular disease

- Patients with a history of cancer other than skin cancer within five years of the
initiation of protocol treatment

- Patients with a history of pelvic irradiation for any reason