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Clinical Trial NCT05364229 (MRL-Boost PC) for Prostate Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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MR-guided Tumour Boost (MRL-Boost PC) 40

Active, not recruiting
Clinical Trial NCT05364229 (MRL-Boost PC) is an interventional study for Prostate Cancer that is active, not recruiting. It started on 6 February 2023 with plans to enroll 40 participants. Led by University Health Network, Toronto, it is expected to complete by 1 June 2030. The latest data from ClinicalTrials.gov was last updated on 5 March 2026.
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.
Official Title

MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer

Conditions
Prostate Cancer
Other Study IDs
  • MRL-Boost PC
  • 21-6162
NCT ID Number
NCT05364229
Start Date (Actual)
2023-02-06
Last Update Posted
2026-03-05
Completion Date (Estimated)
2030-06
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
prostate cancer
SBRT
stereotactic body radiotherapy
tumour boost
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMR-guided Tumour Boost with SBRT
MR-guided radiotherapy boost to MRI visible tumour
MR-guided Radiotherapy Boost
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 Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Baseline
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Baseline to 5-year follow-up
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
Baseline to 5-year follow-up
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)
Baseline to 5-year follow-up
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • 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

  • 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
University Health Network, Toronto logoUniversity Health Network, Toronto
No contact data.
1 Study Locations in 1 Countries

Ontario

University Health Network, Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada