Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy

Study Overview
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Brief Summary
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This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.

Official Title
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Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: RapidStrand seeds for use with 18g needle
* Device: ThinStrand


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0 Greater than or equal to 40 years of age Low and Low- Intermediate Risk prostate cancer Prostate volumes by TRUS ≤ 60 cc I-PSS score < 25 (alpha blockers allowed) Signed study-specific informed consent form prior to study entry Exclusion Criteria: Lymph node involvement (N1) Evidence of distant metastases (M1) Radical surgery for carcinoma of the prostate Prior pelvic radiation Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires Hip prosthesis Inability or refusal to provide informed consent Evidence of Previous TURP Prior hormone therapy Prior TURP

Ages Eligible for Study
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Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iodine-125 standard 18 g needle<br>Rapidstrand | Device: RapidStrand seeds for use with 18g needle<br>* Rapidstrand seeds are standard size and are used with 20 g needles<br>* Other names: Both Rapidstrand and Thinstrand are manufactured by Oncura;Device: ThinStrand<br>* ThinStrand seeds are smaller in diameter and used with 20g needles<br>* Other names: Both ThinStrand and RapidStrand are manufactured by Oncura.;|
| Active Comparator: 20 g needle<br>Thin Strand | Device: RapidStrand seeds for use with 18g needle<br>* Rapidstrand seeds are standard size and are used with 20 g needles<br>* Other names: Both Rapidstrand and Thinstrand are manufactured by Oncura;Device: ThinStrand<br>* ThinStrand seeds are smaller in diameter and used with 20g needles<br>* Other names: Both ThinStrand and RapidStrand are manufactured by Oncura.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire | Randomized | 1 year | 

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