Clinical trial · Interventional
[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
NCT04528199CI-TRIAL-00072999terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Principal Investigator decided to terminate the study because the PI left Hopkins.
Summary
Brief summary (as posted)
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]FLOR (FC303) Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]FLOR (FC303)
- description
- \[18F\]FLOR (FC303) PET/CT imaging.
- interventionNames
- Drug: [18F]FLOR (FC303) Injection
Primary outcomes (1)
- measure
- Incidence of study drug emergent adverse events
- timeFrame
- Up to 10 days post-study drug dosing
- description
- Incidence of study drug emergent adverse events will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males ≥18 years of age. * Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. * Histologically confirmed adenocarcinoma of the prostate. * Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1. * At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease * Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator. Exclusion Criteria: * Subjects administered any radioisotope within five physical half-lives prior to study drug injection. * Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
References
Publications (0)
Data not yet available
No reference posted for this study.