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NCT Number: NCT01936883

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 12 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

Treatment and study plan

HDR

Radiation

High dose rate brachytherapy

LDR

Radiation

Low dose rate brachytherapy boost

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • BC Cancer Foundation

Registry information

Official study title

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

Acronym: BrachyQOL

Important dates

Study start
2014
Primary completion
2019
Study completion
2029
First posted
Sep 6, 2013
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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