Prostate Cancer
Conditions
Keywords
prostatic neoplasm, brachytherapy, quality of life, high dose rate, low dose rate
Brief summary
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
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.
Interventions
RADIATIONHDR
High dose rate brachytherapy
RADIATIONLDR
Low dose rate brachytherapy boost
Sponsors
British Columbia Cancer Agency
BC Cancer Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life long term | 5 years | Quality of Life will be assessed to 5 years using the validated instruments International Prostate Symptom Score, International Index Erectile Function and EPIC |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJuanita M Crook, MD
British Columbia Cancer Agency
Outcome results
None listed