NCT04053842CompletedPhase 2
Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy
Multi-modality Prostate Cancer Image Guided Interventions - 5
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 8 Aug 2019
- Start date
- 4 Feb 2021
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Glenn Bauman
- Diseases
- Prostate cancer
- NCT number
- NCT04053842
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 16
- From 4 Feb 2021 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Contraindication to MRI
- pacemaker or other electronic implants
- known metal in the orbit
- cerebral aneurysm clips
Other illness
- Allergy to contrast agents to be used as part of the imaging panel
Lab values
- 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
Other
- Inability to comply with the pre-operative imaging panel
- Patients scheduled for radical prostatectomy with prostate size exceeding 65 cc
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.