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

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ClinicalTrials.gov Identifier: NCT01936883
Recruitment Status : Recruiting
First Posted : September 6, 2013
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
British Columbia Cancer Agency

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
Prostate Cancer Radiation: HDR Radiation: LDR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 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 :
  1. Quality of Life long term [ Time Frame: 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:
  1. Efficacy [ Time Frame: 8 years ]
    regular PSA monitoring every 6 months to 3 years and then annually to determine PSA recurrence free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936883


Contacts
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Contact: Francois Bachand, MD 250 979 6645 fbachand@bccancer.bc.ca
Contact: Juanita M Crook, MD 250 979 6645 jcrook@bccancer.bc.ca

Locations
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Canada, British Columbia
British Columbia Cancer Agency Center for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y5L3
Contact: Francois Bachand, MD    250 979 6645    fbachand@bccancer.bc.ca   
Contact: Juanita Crook, MD    250 979 6645    jcrook@bccancer.bc.ca   
Sub-Investigator: Ross Halperin, MD         
Sub-Investigator: Matt Schmidt, MSc         
Sub-Investigator: Deidre Batchelar, PhD         
Sub-Investigator: Cynthia Araujo, PhD         
Sub-Investigator: David Kim, MD         
Sub-Investigator: David Petrik, MD         
Sub-Investigator: Jim Rose, MD         
Sub-Investigator: Marie-Pierre Millette, PhD         
Sub-Investigator: Michelle Hilts, PhD         
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
Investigators
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Principal Investigator: Francois Bachand, MD British Columbia Cancer Agency
Principal Investigator: Juanita Crook, MD British Columbia Cancer Agency

Publications:

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01936883    
Other Study ID Numbers: H13-02139
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by British Columbia Cancer Agency:
prostatic neoplasm
brachytherapy
quality of life
high dose rate
low dose rate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases