Comparison of HDR vs. LDR Brachytherapy as Monotherapy for Intermediate Risk Prostate Cancer

NCT02692105 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: H15-02103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will offer men with intermediate risk prostate cancer who are suitable for, and interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as a standard of care in BC but only when used as a boost in addition with external beam radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.

Conditions

Prostate Cancer

Keywords

prostate adenocarcinoma; intermediate risk group; brachytherapy; High Dose Rate vs Low Dose Rate; Quality of Life

Outcome Measures

Primary Outcomes (1)

• The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.

  The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.

  0-36 months

Secondary Outcomes (7)

• Quality of Life in the bowel and sexual domains

  0-36 months

• Time to return to baseline +/- 3 points for the International Prostate Symptom Score

  0-36 months

• Acute and long term toxicity

  0-10 years

• TRUS- MRI fusion

  baseline

• Biochemical Outcome

  5-10 years

Study Arms (2)

Low dose rate brachytherapy

ACTIVE COMPARATOR

Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.

Radiation: Low dose rate prostate brachytherapy

High dose rate brachytherapy

EXPERIMENTAL

Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.

Radiation: High Dose Rate prostate brachytherapy

Interventions

Low dose rate prostate brachytherapy RADIATION

Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance

Also known as: LDR brachytherapy, seed brachytherapy

Low dose rate brachytherapy

High Dose Rate prostate brachytherapy RADIATION

Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate

Also known as: HDR brachytherapy

High dose rate brachytherapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8
• ECOG 0-1
• Low tier intermediate-risk prostate cancer is defined by;
• o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA \< 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)
• Extensive favorable-risk disease is defined as:
• clinical stage T1c-T2a
• PSA \< 10
• Gleason 6
• ≥ 50% of biopsy cores containing cancer
• PSA density \> 0.2 ng/cc
• Selected intermediate risk patients not defined above
• \- T1c/T2a
• \- PSA \< 10
• Gleason 4+3
• \< 33% of cores involved

You may not qualify if:

• Prior radical surgery for carcinoma of the prostate,
• Prior pelvic radiation
• Prior chemotherapy for prostate cancer,
• Prior TURP or cryosurgery of the prostate
• Claustrophobic or unable to undergo MRI

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

Location

Related Publications (3)

• Crook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20.

  PMID: 24958556 BACKGROUND

• Batchelar D, Gaztanaga M, Schmid M, Araujo C, Bachand F, Crook J. Validation study of ultrasound-based high-dose-rate prostate brachytherapy planning compared with CT-based planning. Brachytherapy. 2014 Jan-Feb;13(1):75-9. doi: 10.1016/j.brachy.2013.08.004. Epub 2013 Sep 27.

  PMID: 24080299 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

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

• Ross Halperin, MD

  British Columbia Cancer Agency Program Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 25, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)