NCT00619515

Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	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).
PROCEDURE	implanted fiducial-based imaging	Undergo fiducial placement imaging
RADIATION	stereotactic radiosurgery	Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-09-01
• Completion: 2013-02-01
• First posted: 2008-02-21
• Last updated: 2019-08-22
• Results posted: 2019-08-22

Locations

4 sites across 1 country: United States