BrachyQOL: Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: LDR boost 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
Low dose rate brachytherapy boost
|
| Active Comparator: HDR boost 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
High dose rate brachytherapy
|
Outcome Measures
Primary Outcome Measures
- Quality of Life [6 months]
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
Secondary Outcome Measures
- Quality of Life long term [3 years]
Quality of Life will be assessed to 3 years using the validated instruments International Prostate Symptom Score, International Index Erectile Function and EPIC
Other Outcome Measures
- Efficacy [8 years]
regular PSA monitoring every 6 months to 3 years and then annually to determine PSA recurrence free survival
Eligibility Criteria
Criteria
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
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History and physical examination within 90 days prior to registration
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European Cooperative Oncology Group performance status 0-1 prior to registration
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Age >45
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | British Columbia Cancer Agency Center for the Southern Interior | Kelowna | British Columbia | Canada | V1Y5L3 |
Sponsors and Collaborators
- British Columbia Cancer Agency
- BC Cancer Foundation
Investigators
- Principal Investigator: Francois Bachand, MD, British Columbia Cancer Agency
- Principal Investigator: Juanita Crook, MD, British Columbia Cancer Agency
Study Documents (Full-Text)
None provided.More Information
Publications
- Bachand F, Martin AG, Beaulieu L, Harel F, Vigneault E. An eight-year experience of HDR brachytherapy boost for localized prostate cancer: biopsy and PSA outcome. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):679-84. doi: 10.1016/j.ijrobp.2008.05.003. Epub 2008 Oct 27.
- Deutsch I, Zelefsky MJ, Zhang Z, Mo Q, Zaider M, Cohen G, Cahlon O, Yamada Y. Comparison of PSA relapse-free survival in patients treated with ultra-high-dose IMRT versus combination HDR brachytherapy and IMRT. Brachytherapy. 2010 Oct-Dec;9(4):313-8. doi: 10.1016/j.brachy.2010.02.196. Epub 2010 Aug 4.
- Morton GC, Loblaw DA, Chung H, Tsang G, Sankreacha R, Deabreu A, Zhang L, Mamedov A, Cheung P, Batchelar D, Danjoux C, Szumacher E. Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1299-305. doi: 10.1016/j.ijrobp.2010.04.046. Epub 2010 Aug 12.
- Pieters BR, de Back DZ, Koning CC, Zwinderman AH. Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. Radiother Oncol. 2009 Nov;93(2):168-73. doi: 10.1016/j.radonc.2009.08.033. Epub 2009 Sep 11. Review.
- Schmid M, Crook JM, Batchelar D, Araujo C, Petrik D, Kim D, Halperin R. A phantom study to assess accuracy of needle identification in real-time planning of ultrasound-guided high-dose-rate prostate implants. Brachytherapy. 2013 Jan-Feb;12(1):56-64. doi: 10.1016/j.brachy.2012.03.002. Epub 2012 Apr 17.
- Stock RG, Stone NN, Cesaretti JA, Rosenstein BS. Biologically effective dose values for prostate brachytherapy: effects on PSA failure and posttreatment biopsy results. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):527-33. Epub 2005 Oct 19.
- H13-02139