LDR vs. HDR Brachytherapy for Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: High dose rate prostate brachytherapy; Radiation: Low dose rate prostate brachytherapy

• Registration Number: NCT03426748
• Lead Sponsor: British Columbia Cancer Agency

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.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-08
• Study Start: 2018-02-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 140

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
  • -< 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose rate brachytherapy	High dose rate prostate 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.
Low dose rate brachytherapy	Low dose rate prostate 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.

Primary Outcome Measures

Name	Time	Method
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.	0-36 months	The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.

Secondary Outcome Measures

Name	Time	Method
Quality of Life in the bowel and sexual domains	0-36 months	The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24 and 36 months
Time to return to baseline +/- 3 points for the International Prostate Symptom Score	0-36 months	The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24 and 36 months
Histologic Outcome	3 years	Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment
Acute and long term toxicity	[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
Tumor oxygenation and cell cycle distribution	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
Biochemical Outcome	5-10 years	PSA will be recorded every 6 months to 5 years and then annually to 10 years
Cell cycle progression score	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.

Trial Locations

Locations (1)

British Columbia Cancer Agency Center for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada