Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a short course (five radiation treatments) of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

Detailed Description
-----------------
External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.

Official Title
-----------------
Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate

Conditions
-----------------
Prostatic Neoplasm

Intervention / Treatment
-----------------
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension. Exclusion Criteria: Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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
Interventional Model Description: Radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT<br>Stereotactic Body Radiation Therapy | Radiation: radiation therapy<br>* Stereotactic Body Radiation Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute and late toxicity to the GU and GI systems | acute and late toxicity to the GU and GI systems based on the RTOG definitions will be compared to those of standard radiation therapy. | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop in the PSA (biochemical marker) | One year biochemical control rate of >90%. | 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasms, Urogenital neoplasm, Genital neoplasms, male