CyberKnife Radiosurgery for Locally Recurrent Prostate CA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment. This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.

Official Title
-----------------
VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy. Karnofsky performance status >80. Greater than 5 year life expectancy Greater than 2 years since the original course of radiotherapy. Absence of distant metastases by radiologic or pathologic assessment. Absence of lymph node involvement by radiologic or pathologic assessment. Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria: Stage T4 disease (AJCC 6th Edition, see Appendix II). Less than 2 years since the original course of radiotherapy. Lymph node involvement (N1). Evidence of distant metastases (M1). Radical surgery for carcinoma of the prostate Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years. Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. History of inflammatory bowel disease Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Other: CyberKnife Radiosurgery<br>Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy. | Radiation: CyberKnife Radiosurgery<br>* CyberKnife Radiosurgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish pattern of PSA decline |  | Post CyberKnife Radiosurgery - 5 year f/up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer |  | Post CyberKnife Radiosurgery/5 yr. f/up |