MR-guided Tumour Boost (MRL-Boost)

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University Health Network, Toronto

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Radiation: MR-guided Radiotherapy Boost

Study type

Interventional

Funder types

Other

Identifiers

NCT05364229
21-6162

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

MR-guided Tumour Boost with SBRT
Experimental group
Description:
MR-guided radiotherapy boost to MRI visible tumour
Treatment:
Radiation: MR-guided Radiotherapy Boost

Trial contacts and locations

1

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Central trial contact

Peter Chung, MD

Data sourced from clinicaltrials.gov

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