Status:
RECRUITING
MR-guided Tumour Boost
Lead Sponsor:
University Health Network, Toronto
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 radi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05364229
Start Date
February 6 2023
End Date
June 1 2030
Last Update
March 18 2024
Active Locations (1)
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1
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9