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Prostate CancerLDR/HDRmonoNCT03426748

LDR vs. HDR Brachytherapy for Prostate Cancer

A study testing Low dose rate prostate brachytherapy and High dose rate prostate brachytherapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 40 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Low dose rate prostate brachytherapy and High dose rate prostate brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteCanada
Study dates
15 Feb 2018to 31 Oct 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • British Columbia Cancer Agency Center for the Southern Interior

    Kelowna, British Columbia, V1Y5L3

Other trials in Canada

About this study

Official title: A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

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

Read the 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
Being tested
Low dose rate prostate brachytherapy, High dose rate prostate brachytherapy
Keywords
Brachytherapy, Quality of life, High dose rate vs. low dose rate, Intermediate risk group
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose rate prostate brachytherapyRadiation

    Also called permanent seed implant

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

  • High dose rate prostate brachytherapyRadiation

    Also called HDR 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

Study groups in NCT03426748
Study groupRoleWhat they receive
Low dose rate brachytherapyActive comparatorDevice: 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.
Receives: Radiation: Low dose rate prostate brachytherapy
High dose rate brachytherapyExperimentalDevice: 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.
Receives: Radiation: High dose rate prostate brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0-60 months

Secondary outcomes (7)

  1. Quality of Life in the bowel and sexual domains

    The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months

    Measured: 0-60 months

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

    The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months

    Measured: 0-60 months

  3. Acute and long term toxicity

    Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point

    Measured: [Time Frame: 0-10 years]

  4. Biochemical Outcome

    PSA will be recorded every 6 months to 5 years and then annually to 10 years

    Measured: 5-10 years

  5. Histologic Outcome

    Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment

    Measured: 3 years

  6. Cell cycle progression score

    For those patients consenting to targeted biopsies under anesthesia at the start of their brachytherapy procedure (separate optional consent) MRI-TRUS fusion accuracy will be verified by targeted biopsies and Biopsy material will be sent for genetic testing to determine Cell cycle Progression scores for both arms of the trial to ultimately correlate with outcome.

    Measured: 1 month to 10 years

  7. Tumor oxygenation and cell cycle distribution

    For patients receiving 2 fractions of high dose rate brachytherapy, biopsy between the 2 fractions will assess radiosensitivity by evaluating changes in oxygenation and cell cycle distribution between the 2 fractions, for ultimate correlation with efficacy

    Measured: 1 month to 10 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start15 Feb 2018
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Oct 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426748
Sponsor's protocol ID
H17-02904
Acronym
LDR/HDRmono
Status last verified
Jan 2026
First submitted
2 Feb 2018
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24958556

  • 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.

    PubMed 24080299

  • 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.

    PubMed 22513104

Questions about this trial

What is this clinical trial studying?

A study testing Low dose rate prostate brachytherapy and High dose rate prostate brachytherapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy. (time frame: 0-60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426748, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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LDR vs. HDR Brachytherapy for Prostate Cancer | AzTrials