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.
Eligibility
Sex
MALE
Min age
45 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Upper tier intermediate risk with at least 2 of the following factors
1. Tumor-Nodes-Metastases Tumor stage T2B or greater
2. Gleason Score 7
3. PSA \> 10
4. \> 50% of the biopsies positive
* OR High risk prostate cancer with one of the following factors
1. T3a
2. Gleason Score8-10
3. PSA \>20
* Positive prostate biopsy within 12 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
Primary outcome measure(s)
Compare Quality of Life between two arms as measured by EPIC questionnaire — 6 months Quality of life will be measured through validated instruments including International Prostate Symptom Score (IPSS), the International Index of Erectile Function ((IEF), and the urinary, bowel and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). IPSS has 7 questions related to voiding symptoms, each scored 0-5, with a higher score indicating worse symptoms. IIEF has 5 questions, each scored 0-5 with a higher score indicating better function. EPIC has several questions for each domain with an overall higher score associated with better QoL in that domain.
Trial sites (1)
Facility
City
Region
Status
British Columbia Cancer Agency Center for the Southern Interior
Kelowna
British Columbia
More British Columbia Cancer Agency trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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