MR-guided Tumour Boost

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: MR-guided Radiotherapy Boost

• Registration Number: NCT05364229
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Study Start: 2023-02-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-guided Tumour Boost with SBRT	MR-guided Radiotherapy Boost	MR-guided radiotherapy boost to MRI visible tumour

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient-reported quality-of-life assessed by EPIC-26	Baseline to 5-year follow-up	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)
Acute Toxicity	Baseline to 5-year follow-up	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	Baseline to 5-year follow-up	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

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada