Clinical trial · Interventional
Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy
Multi-modality Prostate Cancer Image Guided Interventions - 5
NCT04053842CI-TRIAL-00087184IGPC-5completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]PSMA-1007 Injection | Drug | — | UNRESOLVED |
| Multiparametric MRI | Diagnostic Test | — | UNRESOLVED |
| PET Scan | Diagnostic Test | — | UNRESOLVED |
| Sodium MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-modality prostate cancer imaging
- description
- The study requires eligible patients to complete one imaging session at St. Joseph's Health Care to begin within 6 weeks of the scheduled Radical Prostatectomy. Imaging will consist of simultaneous multiparametric MRI (mpMRI), sodium MRI and positron emission tomography (PET) with a radio-labeled probe for prostate-specific membrane antigen (PSMA).
- interventionNames
- Diagnostic Test: PET Scan
- Drug: [18F]PSMA-1007 Injection
- Diagnostic Test: Sodium MRI
- Diagnostic Test: Multiparametric MRI
Primary outcomes (1)
- measure
- Pathologic Validation and Modeling
- timeFrame
- 4 years
- description
- We will evaluate the ability of simultaneous multiparametric MRI (mpMRI), sodium MRI and positron emission tomography (PET) with a radio-labeled probe for prostate-specific membrane antigen (PSMA) to accurately predict the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery. A variety of statistical methods will be utilized to build predictive models based on the extracted features and to identify a final model that will be used as the predictive tool (i.e. the imaging assay). We will quantify the ability of these models to enhance clinical lesion identification.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (28)
- BACKGROUNDChun FK, Karakiewicz PI, Briganti A, Walz J, Kattan MW, Huland H, Graefen M. A critical appraisal of logistic regression-based nomograms, artificial neural networks, classification and regression-tree models, look-up tables and risk-group stratification models for prostate cancer. BJU Int. 2007 Apr;99(4):794-800. doi: 10.1111/j.1464-410X.2006.06694.x. PMID 17378842
- BACKGROUNDMakarov DV, Trock BJ, Humphreys EB, Mangold LA, Walsh PC, Epstein JI, Partin AW. Updated nomogram to predict pathologic stage of prostate cancer given prostate-specific antigen level, clinical stage, and biopsy Gleason score (Partin tables) based on cases from 2000 to 2005. Urology. 2007 Jun;69(6):1095-101. doi: 10.1016/j.urology.2007.03.042. PMID 17572194
- BACKGROUNDHricak H, Choyke PL, Eberhardt SC, Leibel SA, Scardino PT. Imaging prostate cancer: a multidisciplinary perspective. Radiology. 2007 Apr;243(1):28-53. doi: 10.1148/radiol.2431030580. PMID 17392247
- BACKGROUNDChan I, Wells W 3rd, Mulkern RV, Haker S, Zhang J, Zou KH, Maier SE, Tempany CM. Detection of prostate cancer by integration of line-scan diffusion, T2-mapping and T2-weighted magnetic resonance imaging; a multichannel statistical classifier. Med Phys. 2003 Sep;30(9):2390-8. doi: 10.1118/1.1593633. PMID 14528961
- BACKGROUNDBarrett T, Turkbey B, Choyke PL. PI-RADS version 2: what you need to know. Clin Radiol. 2015 Nov;70(11):1165-76. doi: 10.1016/j.crad.2015.06.093. Epub 2015 Jul 29. PMID 26231470
- BACKGROUNDKwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20. PMID 18384719
- BACKGROUNDWard AD, Crukley C, McKenzie CA, Montreuil J, Gibson E, Romagnoli C, Gomez JA, Moussa M, Chin J, Bauman G, Fenster A. Prostate: registration of digital histopathologic images to in vivo MR images acquired by using endorectal receive coil. Radiology. 2012 Jun;263(3):856-64. doi: 10.1148/radiol.12102294. Epub 2012 Apr 2.