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

NCT01936883 | Active Not Recruiting DMC

• 1 other identifier: H13-02139
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostatic neoplasm; brachytherapy; quality of life; high dose rate; low dose rate

Outcome Measures

Primary Outcomes (1)

• Compare Quality of Life between two arms as measured by EPIC questionnaire

  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 Outcomes (1)

• Quality of Life long term

  5 years

Other Outcomes (1)

• Efficacy: cancer free status

  10 years

Study Arms (2)

LDR boost

ACTIVE COMPARATOR

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

HDR boost

ACTIVE COMPARATOR

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

Interventions

LDR RADIATION

Low dose rate brachytherapy boost

LDR boost

HDR RADIATION

High dose rate brachytherapy

HDR boost

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator

Study Sites (1)

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

Location

Related Publications (6)

• 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.

  PMID: 18963537 BACKGROUND

• 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.

  PMID: 22513104 BACKGROUND

• 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.

  PMID: 20708853 BACKGROUND

• 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.

  PMID: 19748692 BACKGROUND

• 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.

  PMID: 20685176 BACKGROUND

• 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.

  PMID: 16242258 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Juanita M Crook, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)