Clinical trial · Interventional
Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
Prospective Study Evaluating the Role of Axumin® (Fluciclovine or 18F-FACBC) PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
- 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 prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
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 |
|---|---|---|---|
| Fluciclovine PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluciclovine PET/CT
- description
- Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.
- interventionNames
- Drug: Fluciclovine PET/CT
Primary outcomes (1)
- measure
- Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
- timeFrame
- During PET scan procedure
Secondary outcomes (3)
- measure
- Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.
- timeFrame
- During PET scan procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years. * Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed. * Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy. * PSA of 0.2 ng/mL or higher within 45 days of the scan. Exclusion Criteria: * Uncontrolled serious infection. * Intercurrent illness or condition that would limit compliance with study requirements. * Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.
References
Publications (0)
Data not yet available