Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

Detailed Description
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This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.

Official Title
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A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: SBRT Prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment Gleason score less than or equal to 7 Clinical Stage T1-T2c PSA less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or less than or = 10 ng/ml prior to start of therapy if Gleason = 7 Zubrod Performance Status 0-1 Age > 40 Exclusion Criteria: Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible) Evidence of distant metastases Regional lymph node involvement Significant urinary obstruction Estimated prostate gland > 100 grams Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy Previous or concurrent cytotoxic chemotherapy for prostate cancer Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip). Severe, active comorbidity

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 82 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: Stereotactic Radiotherapy<br>Five fractions of 7.4 Gy each | Radiation: SBRT Prostate<br>* Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.<br>* Other names: External beam radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Genitourinary Acute Toxicity | Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment | </= 90 days post radiation treatment, a total of 90 days | 
| Number of Participants With Genitourinary Late Toxicity | Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment | >90 days from the end of treatment, up to 3 years | 
| Number of Participants With Gastrointestinal Acute Toxicity | Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment | </= 90 days post radiation treatment, a total of 90 days | 
| Number of Participants With Gastrointestinal Late Toxicity | Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment | >90 days from the end of treatment, up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival |  | 5 yrs | 
| Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form | The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life. | 3 years post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CaP, SBRT, Prostate, ExacTrac, Calypso, IMRT, Radiation, Cancer of Prostate, Prostatic Neoplasms