๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-03-11

Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy (NCT04053842)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Glenn Bauman

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The study is a non-randomized, prospective trial of men scheduled for radical prostatectomy for treatment of prostate cancer as standard of care and will undergo a series of pre-operative multi-modality imaging studies. Pre-operative imaging will be correlated with actual pathology results and statistical modeling performed to determine the most informative imaging biomarkers in predicting cancer location and aggressiveness (Gleason Score).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (13 items).

Location: London Health Sciences Centre โ€” London, Ontario

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Prior therapy for prostate cancer (including hormone therapy)
  • Use of 5-alpha reductase inhibitors, i.e. finasteride (Proscar) or dutasteride (Avodart) within 6 months of study start. Patients undergoing a 6-month washout period prior to study start will be eligible.
  • Inability to comply with the pre-operative imaging panel
  • Patients scheduled for radical prostatectomy with prostate size exceeding 65 cc
  • Allergy to contrast agents to be used as part of the imaging panel
  • Acute kidney injury (AKI), chronic kidney disease (CKD) Stage 4 or 5 (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min/1.73m2) or those on dialysis
  • Post-void residual urine volume \> 150 cc (determined by post-void ultrasound)
  • Hip prosthesis, vascular grafting that is MRI incompatible or sources of artefact within the pelvis
  • Contraindication to MRI
  • pacemaker or other electronic implants
  • known metal in the orbit

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • London Health Sciences Centre โ€” London, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—