Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.

Detailed Description
-----------------
Objectives: Primary -Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer Secondary Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer Determine the treatment planning and dosimetric feasibility Evaluate the treatment delivery quality assurance Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer Patients will undergo 5 total radiation treatments over 7-17 day period. Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2. After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.

Official Title
-----------------
RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity, Sexual Dysfunction

Intervention / Treatment
-----------------
* Radiation: Stereotactic Body Radiation Therapy with Integrated Boost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration NCCN risk category very low, low, or intermediate risk Combined Gleason score <7 PSA within three months of enrollment < 20ng/ml Clinical stage T1a-c N0M0 or clinical stage T2aN0M0 Life expectancy > 5 years Risk of malignant lymph node involvement < 15% as calculated on Partin tables Karnofsky performance status (KPS) > 60 Age > 19 years Subjects given written informed consent Exclusion Criteria: History of inflammatory bowel disease Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria. Platelet count < 70 Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria. Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy). Risk of malignant lymph node involvement > 15% as calculated on Partin tables.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Stereotactic Body Radiation Therapy with Integrated Boost<br> | Radiation: Stereotactic Body Radiation Therapy with Integrated Boost<br>* SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions<br>* Other names: VMAT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer | Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals. | Within 3 months of the completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Planning Feasibility | Feasibility will be defined as the ability of the treatment planner to create a plan that meets the following criteria: 100% of radiation target prescription (36.25 Gy) covers greater than or equal to 95% of the target (prostate) At least 95% of the boost prostate (area within the prostate most likely harboring cancer) prescription (38.0 Gy) covers 95% of this boost target volume All normal tissue dose constraints are met -i.e., nearby rectum, bladder, and femoral heads do not exceed the recommended radiation dose limits If the physician must utilize a plan that compromises target coverage or normal tissue dose constraints to levels not meeting the criteria above, then the plan will be scored as not meeting technical feasibility requirements. | Within 6 months of completion of radiation therapy | 
| Early Efficacy | Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer at each interval follow-up visit (every three months for year one, then every 6 months for year two after treatment). Absence of prostate cancer is defined as no evidence of tumor recurrence by two methods: No prostate cancer recurrence evident on the physical examination performed by the physician. No rise in the PSA more than 2 ng/ml above the lowest PSA value ever obtained pre or post treatment. A rise in the PSA more than 2 ng/ml from a patient's lowest value is the standard definition for post-radiation PSA biochemical prostate cancer failure. | Within 6 months of completion of radiation therapy | 
| Number of Patients Who Experienced Late Toxicity | Late toxicity (defined as toxicity occuring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires. | Within 6 months of completion of radiation therapy | 
| Median Quality of Life Score | Median of quality of life score will be assessed with regular clinical exams and patient quality of life questionnaires (American Urologic Association Symptom Index score ranges from 0 to 35 with the higher scores indicating more severe, Sexual Health Inventory score ranges from 1 to 25 with 1 being severe and 25 being no signs, Extended Prostate Cancer Index Composite- Bowel, Extended Prostate Cancer Index Composite- Urinary, and Extended Prostate Cancer Index Composite- Sexual scales range from 1 (worst) to 100 (best)). | Within 6 months of completion of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Prostate Adenocarcinoma, SBRT, Stereotactic Body Radiation Therapy, Radiation