Clinical trial · Expanded Access
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer
NCT04809584CI-TRIAL-00083913approved for marketingClinicalTrials.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 research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18-DCFPyL | Drug | — | UNRESOLVED |
| Gadolinium | Drug | — | UNRESOLVED |
| Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is older than 18-year-old 2. Biopsy proven prostate adenocarcinoma 3. Planned prostatectomy with lymph node dissection 4. Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors) 5. Able to provide written consent 6. Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent) Exclusion Criteria: 1. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu) 2. Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery 3. Metallic implants (contraindicated for MRI)
References
Publications (0)
Data not yet available
No reference posted for this study.