Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate
I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT
fractionation schedule without experiencing a treatment limiting toxicity.
I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria
At 2 years
Michael G. Chang, MD
Virginia Commonwealth University
United States: Institutional Review Board
|Virginia Commonwealth University||Richmond, Virginia|
|Hunter Holmes McGuire Veterans Administration Medical Center||Richmond, Virginia 23249|