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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HDR
LDR
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostatic neoplasm, brachytherapy, quality of life, high dose rate, low dose rate

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Cancer Agency Center for the Southern Interior

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LDR boost

HDR boost

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2013
Last Updated
April 12, 2023
Sponsor
British Columbia Cancer Agency
Collaborators
BC Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01936883
Brief Title
Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy
Acronym
BrachyQOL
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
BC Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostatic neoplasm, brachytherapy, quality of life, high dose rate, low dose rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDR boost
Arm Type
Active Comparator
Arm Description
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
Arm Title
HDR boost
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
HDR
Intervention Description
High dose rate brachytherapy
Intervention Type
Radiation
Intervention Name(s)
LDR
Intervention Description
Low dose rate brachytherapy boost
Primary Outcome Measure Information:
Title
Quality of Life
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life long term
Description
Quality of Life will be assessed to 5 years using the validated instruments International Prostate Symptom Score, International Index Erectile Function and EPIC
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Efficacy: cancer free status
Description
regular PSA monitoring every 6 months to 3 years and then annually to determine PSA recurrence free survival
Time Frame
10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juanita M Crook, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y5L3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18963537
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.
Results Reference
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PubMed Identifier
22513104
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.
Results Reference
background
PubMed Identifier
20708853
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.
Results Reference
background
PubMed Identifier
19748692
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.
Results Reference
background
PubMed Identifier
20685176
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.
Results Reference
background
PubMed Identifier
16242258
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.
Results Reference
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Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy

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