Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Study Overview
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Brief Summary
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In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Detailed Description
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In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Official Title
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Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: CyberKnife Boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the prostate Gleason score (2-10) Biopsy within six months of date of registration Patient age >18 years Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined by physical exam (Digital Rectal Exam Required) i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging b. N-stage determined using abdominopelvic CT scan and/or MRI c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes) Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan. Patients must belong to one of the following risk groups: PSA > 20 and < 150 and/or Gleason 8-10 and/or > clinical T3a and/or Clinical N1 OR PSA 10 - 20 AND Gleason 7 AND Clinical T2b - T2c Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes. Prostate volume greater than 20 cc and less than 100 cc Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patient has agreed to complete questionnaires Signed IRB approved informed consent Patient eligible to have an MRI Must be able to tolerate the confinement of an MRI procedure Exclusion Criteria: No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy No prior radiotherapy to the pelvis No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery No metastatic disease, with the exception of lymph node positive disease No chemotherapy for a malignancy in the last 5 years. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain No history of a pelvic or horseshoe kidney No diagnosis of inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boost<br>CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day | Radiation: CyberKnife Boost<br>* 21 Gy in 7 Gy per day, 3 fractions, Every other day<br>* Other names: stereotactic radiotherapy, cyberknife, radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document rate of biochemical Disease-Free Survival (bDFS) | To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of local failure | Rate of local failure | 5 years | 
| Rate of distant failure | Rate of distant failure | 5 years | 
| disease-free survival | disease-free survival | 5 years | 
| Rate of disease-specific survival | Rate of disease-specific survival | 5 years | 
| Rate of overall survival | Rate of overall survival | 5 years | 
| Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity | rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate