Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Procedure: implanted fiducial-based imaging
* Radiation: stereotactic radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Disease confirmed by biopsy within 1 year of study entry Gleason score 2-7(3+4) Clinical stage T1a or T2b, N0 or NX, M0 or MX T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI) M-stage determined by physical exam, CT scan, and/or MRI Bone scan is not required unless clinical findings suggest possible osseous metastases PSA ≤ 10 ng/mL within the past 60 days At risk for recurrence, as defined by 1 of the following risk groups: Low-risk, defined by the following combination: Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL Low- to-Intermediate-risk, defined by either of the following combinations: Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL Prostate volume must be ≤ 100 cc Determined by measurement from CT scan or ultrasound within the past 90 days or within the past 14 days if hormone therapy is given PATIENT CHARACTERISTICS: ECOG performance status 0-1 No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion PRIOR CONCURRENT THERAPY: No prior definitive therapy for prostate cancer, including prostatectomy, cryotherapy, or radiotherapy to the prostate or lower pelvis No more than 6 months of hormone ablation for gland downsizing

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyberKnife® stereotactic radiosurgery<br> | Other: questionnaire administration<br>* 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).<br>Procedure: implanted fiducial-based imaging<br>* Undergo fiducial placement imaging<br>Radiation: stereotactic radiosurgery<br>* Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Grade 3-5 Adverse Events 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0 | 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. | Within 5 years of completing treatment | 
| Biochemical Disease-free Survival | PSA | Assessed at months 3,6,12,18,24 and every 6 months through 5 years | 
| Disease-free Survival (Phoenix and ASTRO Definitions) |  | Assessed yearly for 5 years | 
| Disease-specific Survival |  | Assessed yearly for 5 years | 
| Overall Survival |  | Assessed yearly for 5 years | 
| Rate of Local Failure |  | Assessed at months 3,6,12,18,24 and every 12 months through 5 years | 
| Rate of Distant 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer