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

April 10, 2024 updated by: British Columbia Cancer Agency

IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y5L3
        • British Columbia Cancer Agency Center for the Southern Interior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Quality of Life between two arms as measured by EPIC questionnaire
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life long term
Time Frame: 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
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: cancer free status
Time Frame: 10 years
regular PSA monitoring every 6 months to 3 years and then annually to determine PSA recurrence free survival
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

BC Cancer Foundation

Investigators

  • Principal Investigator: Juanita M Crook, MD, British Columbia Cancer Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimated)

September 6, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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