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MR-guided Tumour Boost (MRL-Boost)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MR-guided Radiotherapy Boost
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, SBRT, stereotactic body radiotherapy, tumour boost

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically-proven localized prostate cancer.
  • Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor)
  • Low-risk: cT1-T2a, PSA <10, and Gleason score 6
  • Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7
  • High-risk limited to 1 risk factor: >T2, PSA >20, or Gleason score >7
  • Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/< 1/3 total prostate volume
  • Planned for EBRT (+/- ADT)
  • ECOG 0 or 1
  • 18 years of age or older
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Prior radiotherapy to pelvis
  • Radiological evidence of regional or distant metastases at the discretion of the treating physician.
  • Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
  • Ataxia Telangectasia and SLE
  • Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury
  • Severe claustrophobia

Sites / Locations

  • University Health Network, Princess Margaret HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-guided Tumour Boost with SBRT

Arm Description

MR-guided radiotherapy boost to MRI visible tumour

Outcomes

Primary Outcome Measures

Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost
Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75

Secondary Outcome Measures

Acute Toxicity
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Late Toxicity
Late (more than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Patient-reported quality-of-life assessed by EPIC-26
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1-, 3-, and 6-months post radiation as well as years 1, 2, 3, 4, and 5) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)

Full Information

First Posted
May 3, 2022
Last Updated
February 15, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05364229
Brief Title
MR-guided Tumour Boost
Acronym
MRL-Boost
Official Title
MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
June 2030 (Anticipated)
Study Completion Date
June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

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

5. Study Description

Brief Summary
This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, SBRT, stereotactic body radiotherapy, tumour boost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR-guided Tumour Boost with SBRT
Arm Type
Experimental
Arm Description
MR-guided radiotherapy boost to MRI visible tumour
Intervention Type
Radiation
Intervention Name(s)
MR-guided Radiotherapy Boost
Intervention Description
IMRT/VMAT prostate whole gland SBRT to 30 Gy in 5 fractions. MRL focal boost of 15 Gy in 1 fraction will be delivered either before or after whole gland SBRT.
Primary Outcome Measure Information:
Title
Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost
Description
Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Acute Toxicity
Description
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
Baseline to 5-year follow-up
Title
Late Toxicity
Description
Late (more than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
Baseline to 5-year follow-up
Title
Patient-reported quality-of-life assessed by EPIC-26
Description
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1-, 3-, and 6-months post radiation as well as years 1, 2, 3, 4, and 5) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Time Frame
Baseline to 5-year follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-proven localized prostate cancer. Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor) Low-risk: cT1-T2a, PSA <10, and Gleason score 6 Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7 High-risk limited to 1 risk factor: >T2, PSA >20, or Gleason score >7 Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/< 1/3 total prostate volume Planned for EBRT (+/- ADT) ECOG 0 or 1 18 years of age or older Ability to provide written informed consent to participate in the study Exclusion Criteria: Prior radiotherapy to pelvis Radiological evidence of regional or distant metastases at the discretion of the treating physician. Active ulcerative colitis or Crohn's Disease, at discretion of treating physician Ataxia Telangectasia and SLE Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury Severe claustrophobia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Chung, MD
Phone
416-946-4501
Ext
6522
Email
peter.chung@rmp.uhn.ca
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Chung, MB ChB
Phone
416 946 4501
Ext
6522
Email
Peter.chung@rmp.uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Peter Chung, MB ChB

12. IPD Sharing Statement

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MR-guided Tumour Boost

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