Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Not Applicable

Terminated

Interventions: Other: questionnaire administration
Procedure: implanted fiducial-based imaging
Radiation: stereotactic radiosurgery

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
CyberKnife® stereotactic radiosurgery	implanted fiducial-based imaging	-
CyberKnife® stereotactic radiosurgery	questionnaire administration	-
CyberKnife® stereotactic radiosurgery	stereotactic radiosurgery	-

Primary Outcome Measures

Name	Time	Method
Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0	Within 90 days of completing treatment	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.

Secondary Outcome Measures

Name	Time	Method
Disease-specific Survival	Assessed yearly for 5 years
Overall Survival	Assessed yearly for 5 years
Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0	Within 5 years of completing treatment	Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions.
Biochemical Disease-free Survival	Assessed at months 3,6,12,18,24 and every 6 months through 5 years	PSA
Disease-free Survival (Phoenix and ASTRO Definitions)	Assessed yearly for 5 years
Rate of Local Failure	Assessed at months 3,6,12,18,24 and every 12 months through 5 years
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	Survey at 1,6,12 months and yearly up to 5 years
Rate of Distant Failure	Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Locations (4): University Suburban Health Center
🇺🇸
Cleveland, Ohio, United States
UH-Westlake
🇺🇸
Westlake, Ohio, United States
UHHS Chagrin Highlands Medical Center
🇺🇸
Cleveland, Ohio, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States