Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
- To estimate in both low- and low-to-intermediate-risk groups of patients with prostate
cancer, the rate of acute toxicities observed during the 5 years following CyberKnife®
stereotactic radiosurgery (SRS).
- To estimate the rate of late grade 3-5 toxicities after SRS in these patients.
- To measure biochemical disease-free survival of patients treated with this therapy.
- To measure rates of local failure, distant failure, disease-free survival,
disease-specific survival, and overall survival of patients treated with this therapy.
- To measure quality of life in generic and organ-specific domains in patients treated
with this therapy.
- To evaluate imaging modalities and their potential role in the detection of prostate
cancer persistence, recurrence, and/or progression in patients treated with this
OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate
Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients
undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
Patients complete 4 questionnaires at baseline and periodically during study to assess acute
and late toxicities and quality of life (e.g., overall health status, patient function,
sexual function, and urinary symptoms).
After completion of study therapy, patients are followed for up to 5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of acute toxicities as assessed by NCI CTCAE v3.0
This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.
Within 90 days of completing treatment
Lee E. Ponsky, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UH-Westlake||Westlake, Ohio 44145|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|University Suburban Health Center||South Euclid, Ohio 44121|