LDR vs. HDR Brachytherapy for Prostate Cancer

NCT03426748 | Active Not Recruiting DMC

• 1 other identifier: H17-02904
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103

Conditions

Prostate Cancer

Keywords

Brachytherapy; Quality of life; High dose rate vs. low dose rate; Intermediate risk group

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.

  0-60 months

Secondary Outcomes (7)

• Quality of Life in the bowel and sexual domains

  0-60 months

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

  0-60 months

• Acute and long term toxicity

  [Time Frame: 0-10 years]

• Biochemical Outcome

  5-10 years

• Histologic Outcome

  3 years

Study Arms (2)

Low dose rate brachytherapy

ACTIVE COMPARATOR

Device: Radiation. Low dose rate prostate brachytherapy is delivered under anesthesia 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 anesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.

Radiation: High dose rate prostate brachytherapy

Interventions

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

Low dose rate prostate brachytherapy RADIATION

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

Also known as: permanent seed implant

Low 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:

• Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.
• Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8
• ECOG 0-1
• Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor
• 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
• PSA \> 10 and Gleason 3+4

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
• BC Cancer Foundation: collaborator

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

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: February 15, 2018
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2034
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)