RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial studies 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Low risk - 69.6 Gy in 2.4 Gy fractions to prostate Intermediate risk - delivered in 30 fractions with neoadjuvant and concurrent androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy in 1.68 Gy fractions to lymph nodes High risk - 30 fractions with neoadjuvant, concurrent, and long term adjuvant androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy at 1.68 Gy fractions to lymph nodes
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria
Time frame: At 2 years
Biochemical failure as defined by the Phoenix definition
Time frame: 2 years
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