Primary Outcome Measures:
- Rate of acute toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Rate of late grade 3-5 toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Biochemical disease-free survival [ Designated as safety issue: No ]
- Disease-free survival (Phoenix and ASTRO definitions) [ Designated as safety issue: No ]
- Disease-specific survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Rate of local failure [ Designated as safety issue: No ]
- Rate of distant failure [ Designated as safety issue: No ]
- Quality of life as measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices [ Designated as safety issue: No ]
OBJECTIVES:
Primary
- 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).
Secondary
- 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 therapy.
OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate risk).
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.