Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

Study Overview
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Brief Summary
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This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials. II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer. III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer. OUTLINE: Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.

Official Title
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Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

Conditions
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Adenocarcinoma of the Prostate, Stage III Prostate Cancer

Intervention / Treatment
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* Radiation: stereotactic body radiation therapy
* Other: quality-of-life assessment
* Other: laboratory biomarker analysis
* Drug: androgen deprivation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary non-metastatic adenocarcinoma of the prostate Risk-group classification into the Dâ€™Amico or National Comprehensive Cancer Network (NCCN) â€˜high-riskâ€™ group, as defined by the presence of any one of the following high-risk factors: Pre-biopsy prostate-specific antigen (PSA) >= 20 Biopsy Gleason score 8-10 Clinical stage T3 No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings) No distant metastases, based upon: CT scan or MRI of the pelvis within 120 days prior to registration Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis Karnofsky performance status (KPS) >= 70 Ability to understand, and willingness to sign, the written informed consent Patient will have opted for SBRT among definitive treatment choices Exclusion Criteria: Patients with any evidence of distant metastases Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate Prior pelvic radiotherapy History of Crohnâ€™s disease or Ulcerative colitis

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: Treatment (SBRT)<br>Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. | Radiation: stereotactic body radiation therapy<br>* Undergo SBRT<br>* Other names: stereotactic radiotherapy;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: laboratory biomarker analysis<br>* Correlative studies<br>Drug: androgen deprivation therapy<br>* up to 9 months at the discretion of the treating physician<br>* Other names: androgen suppression therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical progression free survival | Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir. | At 3 years | 
| Biochemical progression free survival | Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir. | At 5 years | 
| Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4 |  | At 4 months | 
| Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4 |  | Up to 5 years | 
| Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire |  | Baseline to up to 5 years |