A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer. The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.

Detailed Description
-----------------
The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Official Title
-----------------
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution

Conditions
-----------------
Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm

Intervention / Treatment
-----------------
* Radiation: CyberKnife Radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age ≥ 21 Histologically proven prostate adenocarcinoma Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition) PSA ≤ 20 ng/ml Prostate volume ≤ 100 cc Patients belonging in one of the following risk groups: Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10 Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, OR CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml Exclusion Criteria: Any histology other than adenocarcinoma Age < 21 KPS <= 40 <70 ECOG Performance Status ≥ 2 Patient weight >350 lbs. (table limitation) Prior XRT to prostate or lower pelvis Prior surgery or cryotherapy to prostate Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion Chemotherapy for a malignancy in the last 5 years History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years Hormone ablation for 2 months prior to enrollment, or during treatment

Ages Eligible for Study
-----------------
Minimum Age: 21 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 Radiosurgery<br> | Radiation: CyberKnife Radiosurgery<br>* 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction<br>* Other names: CyberKnife;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival [bDFS], Phoenix and ASTRO definitions, at 5 and 10 years). To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer. | 5-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains. | 5-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, CyberKnife, Stereotactic, Radiation