This phase II trial studies how well hypofractionated image-guided radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may be an effective treatment for prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT00809991.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Assess the incidence of grade 2 and 3+ genitourinary (GU) and gastrointestinal (GI) toxicity and self-reported quality of life data with image-guided radiation therapy in doses of 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
SECONDARY OBJECTIVES:
I. Assess biochemical, clinical, and pathologic control rates associated with the hypofractionated dose regimen.
II. Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.
OUTLINE:
Patients undergo 16 fractions of hypofractionated image-guided radiation therapy over 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years, and then annually for 3 years.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorDaniel Yeong-Jin Song
