Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate
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.
Interventional
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
Yes
Michael G. Chang, MD
Principal Investigator
Virginia Commonwealth University
United States: Institutional Review Board
MCC-12870
NCT01117935
May 2010
August 2018
Name | Location |
---|---|
Virginia Commonwealth University | Richmond, Virginia |
Hunter Holmes McGuire Veterans Administration Medical Center | Richmond, Virginia 23249 |