Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy

Study Overview
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Brief Summary
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Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy boost to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.

Detailed Description
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Men with intermediate or high risk prostate cancer who are technically suitable for prostate brachytherapy based on prostate size and voiding function and who are interested in this modality of treatment will be approached for randomization between either high dose rate (single 15 Gray) or low dose rate permanent seed implant (110 Gray) brachytherapy. Baseline International Prostate Symptom score, Quality of Life Assessment and International Index of Erectile Function will be recorded and then every 3 months for the first year and every 6 months to 3 years. Androgen deprivation treatment is allowed for 6 or 12 months.

Official Title
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IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: HDR
* Radiation: LDR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upper tier intermediate risk with at least 2 of the following factors Tumor-Nodes-Metastases Tumor stage T2B or greater Gleason Score 7 PSA > 10 > 50% of the biopsies positive OR High risk prostate cancer with one of the following factors T3a Gleason Score8-10 PSA >20 Positive prostate biopsy within 6 months (reviewed centrally) International Prostate Symptom Score < 16 Prostate volume < 60 cc Negative staging CT and Bone scan within 3 months prior to registration History and physical examination within 90 days prior to registration European Cooperative Oncology Group performance status 0-1 prior to registration Age >45 Patient suitable for procedure under anesthesia Exclusion Criteria: Prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer Previous pelvic irradiation or prostate brachytherapy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LDR boost<br>After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy | Radiation: LDR<br>* Low dose rate brachytherapy boost<br>|
| Active Comparator: HDR boost<br>Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment. | Radiation: HDR<br>* High dose rate brachytherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life will be measured through validated instruments including International Prostate Symptom Score, the International Index of Erectile Function, and the urinary, bowel and sexual domains of EPIC | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life long term | Quality of Life will be assessed to 5 years using the validated instruments International Prostate Symptom Score, International Index Erectile Function and EPIC | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatic neoplasm, brachytherapy, quality of life, high dose rate, low dose rate