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NCT05364229 | Recruiting | Prostate Cancer

MR-guided Tumour Boost
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.

Condition or disease

Prostate Cancer

Intervention/treatment

MR-guided Radiotherapy Boost

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer
Actual Study Start Date : February 6, 2023
Estimated Primary Completion Date : June 2030
Estimated Study Completion Date : June 2030
Arm Intervention/treatment

Experimental: MR-guided Tumour Boost with SBRT

MR-guided radiotherapy boost to MRI visible tumour

Radiation: MR-guided Radiotherapy Boost
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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
MR-guided Tumour Boost

Location Details

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MR-guided Tumour Boost

How to Participate

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Locations

Recruiting

Canada, Ontario

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada, Makhj Qqm