Clinical trial · Interventional
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
- 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)
Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients. The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| histology (gold standard) | Procedure | — | UNRESOLVED |
| PET-MR 18f-FACBC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET-MR 18F-FACBC
- interventionNames
- Procedure: PET-MR 18f-FACBC
- Procedure: histology (gold standard)
Primary outcomes (1)
- measure
- Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
- timeFrame
- 7 days
- description
- Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer) * Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection) Exclusion Criteria: * Previous treatment (for example TURP or hormone therapy) * Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)
References
Publications (2)
- RESULTElschot M, Selnaes KM, Sandsmark E, Kruger-Stokke B, Storkersen O, Tessem MB, Moestue SA, Bertilsson H, Bathen TF. A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):695-703. doi: 10.1007/s00259-016-3562-7. Epub 2016 Nov 5. PMID 27817158
- RESULTSelnaes KM, Kruger-Stokke B, Elschot M, Willoch F, Storkersen O, Sandsmark E, Moestue SA, Tessem MB, Halvorsen D, Kjobli E, Angelsen A, Langorgen S, Bertilsson H, Bathen TF. 18F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prostate cancer patients. Eur Radiol. 2018 Aug;28(8):3151-3159. doi: 10.1007/s00330-017-5213-1. Epub 2018 Jan 2. PMID 29294158