Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy.

Official Title
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Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0 Karnofsky Performance Score of 90 to 100 Greater than or equal to 18 years of age Prostate volumes by TRUS ≤ 60 cc I-PSS score < 15 (alpha blockers allowed) Signed study-specific informed consent form prior to study entry Intermediate Risk prostate cancer as determined by the following: Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less Gleason sum 6 or less; PSA >10.0 and < 20.1ng/ml; Stage T2a or less Gleason sum 6 or less; PSA < 10.1; Stage T2b High risk prostate cancer as determined by the following: Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less Gleason Sum > 7; Any PSA; Stage T2c or less Any Gleason Sum; Any PSA; Stage T2c Any two or three intermediate risk factor Exclusion Criteria: Lymph node involvement (N1) Evidence of distant metastases (M1) Any hormonal blockade or therapy that: Has persisted for more than 6 months by time of protocol screening; OR Is ongoing within 3 months of study enrollment Radical surgery for carcinoma of the prostate Prior pelvic radiation Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up Hip prosthesis Inability or refusal to provide 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate. | Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The analysis of treatment related morbidities following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate. | Data collected for analysis will be the EPIC prostate cancer quality of life questionnaire. | 5 years | 
| The analysis of PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate. | Data collected for analysis will be PSA measurements. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, cancer, intermediate risk, high risk, brachytherapy, Cesium-131, seed brachytherapy, intermediate and high risk cancer of the prostate