Clinical trial NCT03426748: LDR vs. HDR Brachytherapy for Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Brachytherapy
Quality of life
High dose rate vs. low dose rate
Intermediate risk group
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: BC Cancer Foundation
First posted: 2018-02-08
Enrollment: 140
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
  * -\< 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

Primary outcomes:
measure: The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
timeFrame: 0-36 months
Secondary outcomes:
measure: Quality of Life in the bowel and sexual domains
timeFrame: 0-36 months
measure: Time to return to baseline +/- 3 points for the International Prostate Symptom Score
timeFrame: 0-36 months
measure: Acute and long term toxicity
timeFrame: [Time Frame: 0-10 years]
measure: Biochemical Outcome
timeFrame: 5-10 years
measure: Histologic Outcome
timeFrame: 3 years
measure: Cell cycle progression score
timeFrame: 1 month to 10 years
measure: Tumor oxygenation and cell cycle distribution
timeFrame: 1 month to 10 years.
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency Center for the Southern Interior
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency Program Director
name: Ross Halperin, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.