Overview

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

Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
Male
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Glenn Bauman
Collaborators:
Centre for Probe Development and Commercialization
United States Department of Defense
University of Western Ontario, Canada
Criteria
Inclusion Criteria:

- Provision of informed consent for this study

- Male, aged 18 years or older

- Pathologically confirmed prostate cancer on previous biopsy

- Suitable for and consenting to Radical Prostatectomy for treatment as standard of care

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

- cerebral aneurysm clips