Clinical trial · Interventional
18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that is given through the vein to take detailed pictures of areas inside the body where the tracer is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the disease has spread.
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 Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FMAU | Drug | — | UNRESOLVED |
| CAT | Device | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Device | — | UNRESOLVED |
| Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-FMAU PET/CT)
- description
- Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT on day 1. Patients then undergo standard of care multiparametic MRI and standard of care transrectal ultrasound-guided biopsy.
- interventionNames
- Device: CAT
- Drug: 18F-FMAU
- Other: Laboratory Biomarker Analysis
- Procedure: Multiparametric Magnetic Resonance Imaging
- Device: Positron Emission Tomography
- Device: Ultrasound
Primary outcomes (3)
- measure
- Proportion of men for whom biopsy cores taken based only on the 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core or the mpMRI-directed prostate biopsies
- timeFrame
- Up to 1 year
- description
- Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled to undergo standard of care biopsy for suspected prostate cancer, or re-biopsy with prior negative systemic biopsy or restaging biopsy in patients with known prostate cancer on active surveillance Exclusion Criteria: * History of myocardial infarction within 6 months of the enrollment * Active infection (except mild upper respiratory infections) * Active prostatitis * Non-prostate cancers currently on treatment
References
Publications (0)
Data not yet available