High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer
PRIMARY OBJECTIVES:
I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for
patients who undergo SBRT for localized prostate cancer.
SECONDARY OBJECTIVES:
I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC)
and American Urological Association (AUA) scores.
II. Assess biochemical control after high-dose SBRT.
OUTLINE:
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days
with at least 40 hours between each fraction in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months,
every 6 months for 4 years, and then annually thereafter.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0
Excessive GI and GU toxicity will be defined as a grade 3 GU toxicity rate of ≥15%.
1.5 months
Yes
Kevin Stephans
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Federal Government
CASE1812
NCT01664130
July 2012
Name | Location |
---|---|
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |