Stereotactic Body Radiotherapy for Prostate Cancer

Study Overview
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Brief Summary
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This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.

Detailed Description
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This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Official Title
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Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: stereotactic body radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age >= 18 years Zubrod performance status of 0-3 T1-3 N0 M0 adenocarcinoma of the prostate Prostate volume ≤ 100 cc Signed study-specific consent form Exclusion Criteria Extension of local tumor to involve adjacent organs other than seminal vesicles (T4) Prostate volume > 100 cc Nodal involvement Metastatic disease Prior pelvic radiotherapy except as part of combination therapy for prostate cancer History of scleroderma Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

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 |
| --- | --- |
| Other: Stereotactic Body Radiotherapy<br>Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. | Radiation: stereotactic body radiotherapy<br>* Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Control Rate | Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The Phoenix definition for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Toxicity Rate | Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, stereotactic radiotherapy