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NCT Number: NCT03426748

LDR vs. HDR Brachytherapy for 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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose rate prostate brachytherapy

Radiation

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

Other names: permanent seed implant

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

Other names: HDR brachytherapy

Primary outcomes

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

    Time frame: 0-60 months

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

Secondary outcomes

  1. Quality of Life in the bowel and sexual domains

    Time frame: 0-60 months

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

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

    Time frame: 0-60 months

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

  3. Acute and long term toxicity

    Time frame: [Time Frame: 0-10 years]

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

  4. Biochemical Outcome

    Time frame: 5-10 years

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

  5. Histologic Outcome

    Time frame: 3 years

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

  6. Cell cycle progression score

    Time frame: 1 month to 10 years

    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.

  7. Tumor oxygenation and cell cycle distribution

    Time frame: 1 month to 10 years.

    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

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • BC Cancer Foundation

Registry information

Official study 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

Acronym: LDR/HDRmono

Important dates

Study start
2018
Primary completion
2026
Study completion
2034
First posted
Feb 8, 2018
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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