LDR vs. HDR Brachytherapy for Prostate Cancer

NCT ID: NCT03426748

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2034-10-31

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

Detailed Description

Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumor Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumor changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose rate brachytherapy

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.

Group Type: ACTIVE_COMPARATOR

Low dose rate prostate brachytherapy

Intervention Type: RADIATION

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

High dose rate brachytherapy

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.

Group Type: EXPERIMENTAL

High dose rate prostate brachytherapy

Intervention Type: 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

Interventions

Low dose rate prostate brachytherapy

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

Intervention Type: RADIATION

High dose rate prostate brachytherapy

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

Intervention Type: RADIATION

Other Intervention Names

permanent seed implant; HDR brachytherapy

Eligibility Criteria

Inclusion Criteria

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
• PSA 10-15 ng/ml and Gleason 4+3
• -< 33% of cores involved
• -Max tumor length in any core 10 mm
• No androgen deprivation therapy (ADT)
• Prostate volume by TRUS ≤ 60 cc.
• Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
• Signed study specific informed consent.

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

BC Cancer Foundation

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross Halperin, MD

Role: STUDY_DIRECTOR

British Columbia Cancer Agency Program Director

Locations

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 24958556 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24080299 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22513104 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H17-02904

Identifier Type: -

Identifier Source: org_study_id