Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

Study Overview
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Brief Summary
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The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.

Detailed Description
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The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx. At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility. A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.

Official Title
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Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer

Conditions
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Prostate Neoplasms

Intervention / Treatment
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* Radiation: TrueBeam stereotactic body radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven prostate adenocarcinoma within 1 year of enrollment Low risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0 Intermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0 ECOG Performance Status 0-1 No prior prostate radiation or other definitive therapy Exclusion Criteria: implanted hardware or other material that would prohibit treatment planning or delivery chemotherapy for a malignancy within the previous 5 years history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years hormone ablation for 2 months prior to treatment or during treatment

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Other: 36.25Gy to prostate in 5 fractions<br>36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study. | Radiation: TrueBeam stereotactic body radiosurgery<br>* 36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute and late GI/GU toxicity rate following treatment | The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy | For the low-risk cohort, the study is powered to compare 5-year bDFS rates observed with TrueBeam STx to 5-year bDFS rates reported with dose-escalated external beam RT. In Beaumont's monotherapy HDR series treating LR patients, 5-yr ASTRO bDFS was 98%; in Demanes' series of 75% LR and 25% IR, this was 96%. Since TB delivers doses similar to HDR monotherapy, a conservative estimate of the success rate for TB is 97.5% for LR patients. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low risk prostate cancer, intermediate risk prostate cancer, stereotactic radiosurgery