Clinical trial NCT01936883: Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy
Official title: IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostatic neoplasm
brachytherapy
quality of life
high dose rate
low dose rate
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: BC Cancer Foundation
First posted: 2013-09-06
Enrollment: 190
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Compare Quality of Life between two arms as measured by EPIC questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life long term
timeFrame: 5 years
Other outcomes:
measure: Efficacy: cancer free status
timeFrame: 10 years
Locations:
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency Center for the Southern Interior
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Juanita M Crook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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. doi: 10.1016/j.ijrobp.2005.07.981. Epub 2005 Oct 19.