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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low dose rate prostate brachytherapy
High dose rate prostate brachytherapy
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Brachytherapy, Quality of life, High dose rate vs. low dose rate, Intermediate risk group

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • British Columbia Cancer Agency Center for the Southern InteriorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low dose rate brachytherapy

High dose rate brachytherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 and 36 months
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 and 36 months
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
Biochemical Outcome
PSA will be recorded every 6 months to 5 years and then annually to 10 years
Histologic Outcome
Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment
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.
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

Full Information

First Posted
February 2, 2018
Last Updated
April 12, 2023
Sponsor
British Columbia Cancer Agency
Collaborators
BC Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03426748
Brief Title
LDR vs. HDR Brachytherapy for Prostate Cancer
Acronym
LDR/HDRmono
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
BC Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Brachytherapy, Quality of life, High dose rate vs. low dose rate, Intermediate risk group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose rate brachytherapy
Arm Type
Active Comparator
Arm 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.
Arm Title
High dose rate brachytherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Low dose rate prostate brachytherapy
Other Intervention Name(s)
permanent seed implant
Intervention Description
Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
Intervention Type
Radiation
Intervention Name(s)
High dose rate prostate brachytherapy
Other Intervention Name(s)
HDR brachytherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
Description
The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.
Time Frame
0-36 months
Secondary Outcome Measure Information:
Title
Quality of Life in the bowel and sexual domains
Description
The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24 and 36 months
Time Frame
0-36 months
Title
Time to return to baseline +/- 3 points for the International Prostate Symptom Score
Description
The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24 and 36 months
Time Frame
0-36 months
Title
Acute and long term toxicity
Description
Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point
Time Frame
[Time Frame: 0-10 years]
Title
Biochemical Outcome
Description
PSA will be recorded every 6 months to 5 years and then annually to 10 years
Time Frame
5-10 years
Title
Histologic Outcome
Description
Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment
Time Frame
3 years
Title
Cell cycle progression score
Description
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.
Time Frame
1 month to 10 years
Title
Tumor oxygenation and cell cycle distribution
Description
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
Time Frame
1 month to 10 years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juanita M Crook, MD
Phone
250 712 3958
Email
jcrook@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Halperin, MD
Organizational Affiliation
British Columbia Cancer Agency Program Director
Official's Role
Study Director
Facility Information:
Facility Name
British Columbia Cancer Agency Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y5L3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanita Crook, MD
Phone
250 712 3958
Email
jcrook@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Deidre Batchelar, PhD
First Name & Middle Initial & Last Name & Degree
Cynthia Araujo, PhD
First Name & Middle Initial & Last Name & Degree
David Kim, MD
First Name & Middle Initial & Last Name & Degree
David Petrik, MD
First Name & Middle Initial & Last Name & Degree
Michelle Hilts, PhD
First Name & Middle Initial & Last Name & Degree
Ross Halperin, MD
First Name & Middle Initial & Last Name & Degree
Moore Jocelyn, MD
First Name & Middle Initial & Last Name & Degree
Koulis Theodora, MD
First Name & Middle Initial & Last Name & Degree
Halperin Ross, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24958556
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.
Results Reference
background
PubMed Identifier
24080299
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.
Results Reference
background
PubMed Identifier
22513104
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.
Results Reference
background

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LDR vs. HDR Brachytherapy for Prostate Cancer

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