TheranosticTrials.org

Clinical Trial · NCT04009174

Multi-modality Prostate Cancer Image Guided Interventions

Overview

This is a non-randomized, prospective trial of men who are scheduled for radical prostatectomy for treatment of prostate cancer, or repeat biopsy for localized prostate cancer as standard of care and who will undergo a series of pre-operative multi-modality imaging studies. Post intervention, hybrid imaging maps (HIM) will be generated and the predictions of the HIM (3D location, volume and grade of cancer) will be correlated with actual pathology results to gauge the performance of the HIM in both radical prostatectomy and biopsy settings.

Sponsor

Sunnybrook Health Sciences Centre

Phase

N/A

Contacts

Dr. Glenn Bauman, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04009174

Drug / Compound

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

FCH

Isotope(s):
Target(s):
  • Phospholipid Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Suitable for and consenting to Radical Prostatectomy for treatment, or repeat biopsy as standard of care
  • Pathologically confirmed prostate cancer on previous biopsy

Exclusion

  • 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.
  • Residual bladder volume \> 150 cc (determined by post-void ultrasound)
  • Prior therapy for prostate cancer (including hormone therapy), with the exception of radiation therapy for Cohort 2 only
  • Patients scheduled for radical prostatectomy with prostate size exceeding dimensions for whole mount pathology slides
  • Insufficient renal function (eGFR \< 60 mL/min/1.73 m2)
  • Inability to comply with the pre-operative imaging panel