Adenocarcinoma of the Prostate Clinical Trial
Official title:
Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate
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.
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