Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.

Official Title
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Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: HDR brachytherapy monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven Adenocarcinoma of the Prostate Clinical stage T1c, T2a or T2b PSA less than 20 ng/ml Gleason Score 6 or 7 Exclusion Criteria: Age less than 18 years Clinical stage T2c, T3 ou T4 Clinical Stage N1 Clinical Stage M1 Prostate Specific Antigen (PSA) more than 20 ng/ml Gleason score 8 or higher IPSS score 19 or higher with alpha-blockers Past radiation therapy to the pelvis History of Collagen Vascular Disease History of Inflammatory Bowel Disease Bilateral Hip Prosthesis

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: HDR brachytherapy monotherapy<br>Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments. | Radiation: HDR brachytherapy monotherapy<br>* Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following: Prostate : V100 > 95% V150 30-35% V200 < 15% D90 > 90% (12,15Gy) Bladder • V75 < 1cc Rectum • V75 < 1cc Urethra V125 = 0cc D10 < 120% Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genito-urinary (GU) toxicity | Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires. | 6 weeks, 2 years and 5 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachytherapy, Monotherapy, HDR