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MR-guided Tumour Boost

Recruiting
18 years of age
Male
Phase N/A

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Overview

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.

Eligibility

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

Study details

Prostate Cancer

NCT05364229

University Health Network, Toronto

19 March 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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