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Completed
NCT04053842
Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy
Conditions: Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 16
Sponsor: Glenn Bauman
Location: London Health Sciences Centre London Ontario
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).
Eligibility 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
Source: ClinicalTrials.gov (NCT04053842). StuddyBuddy aggregates publicly available trial information.