LDR vs. HDR Brachytherapy for Prostate Cancer (LDR/HDRmono)

British Columbia Cancer Agency

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Low dose rate prostate brachytherapy; Radiation: High dose rate prostate brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03426748

H17-02904

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Low dose rate brachytherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Low dose rate prostate brachytherapy

High dose rate brachytherapy

Experimental group

Description:

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.

Treatment:

Radiation: High dose rate prostate brachytherapy