Status:
ACTIVE_NOT_RECRUITING
Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy
Lead Sponsor:
Glenn Bauman
Collaborating Sponsors:
Western University, Canada
United States Department of Defense
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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-modali...
Detailed Description
The over-arching goal is to "improve the quality of life for survivors of prostate cancer" through advanced imaging tools for improved pre-treatment detection and characterization of prostate cancer t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04053842
Start Date
February 4 2021
End Date
September 1 2025
Last Update
March 13 2025
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9