Clinical trial · Interventional
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
NCT03392181CI-TRIAL-00090101active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Conditions
Conditions (1)
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFPyL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL
- interventionNames
- Drug: 18F-DCFPyL
Primary outcomes (1)
- measure
- PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer
- timeFrame
- 5 years
- description
- To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria * Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer * Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease) * Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2 * Patients must be age ≥ 18 years * Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the imaging * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria * Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) * Patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan * Patients may not be receiving any other treatments or investigational agents * Patients with a GFR \<30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria * Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral) * Patients who have received androgen deprivation therapy or prior surgery for prostate cancer * Patients who report taking multivitamins and/or folate supplements on the day of the scan
References
Publications (1)
- DERIVEDLi EV, Schaeffer EM, Ramesh Kumar SKS, Zhou R, Yang XJ, Mana-Ay M, Vescovo M, Ho A, Keeter MK, Carr J, Casalino D, Kocherginsky M, Patel HD, Ross AE, Savas H. Utility of 18F-DCFPyL PET for local staging for high or very high risk prostate cancer for patients undergoing radical prostatectomy. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2335-2342. doi: 10.1007/s00259-025-07133-1. Epub 2025 Feb 10. PMID 39928105