Clinical trial · Observational
A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET
Prospective Evaluation of Fluciclovine (18F) PET/CT in Patients with Prior Negative PSMA PET/CT
NCT06859203CI-TRIAL-00086810REFINErecruitingClinicalTrials.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 REFINE study is evaluating whether a fluciclovine (18F) PET/CT scan can detect recurrent prostate cancer in patients whose previous PSMA PET/CT was negative or inconclusive.
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 |
|---|---|---|---|
| Biochemical Recurrence of Malignant Neoplasm of Prostate | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Prostate cancer patients with biochemical recurrence after negative/inconclusive PSMA PET/CT
- description
- This cohort comprises male patients with biochemically recurrent prostate cancer following definitive treatment-such as surgery or radiotherapy-who have previously undergone a PSMA PET/CT scan that was either negative or inconclusive. The primary intervention of interest is the fluciclovine (18F) PET/CT scan, which is performed as part of their routine clinical care to detect sites of recurrent disease.
Primary outcomes (1)
- measure
- Patient-level detection rate
- timeFrame
- From enrollment to the end of observation at 1 year
- description
- The patient-level detection rate of fluciclovine (18F) PET/CT in patients with a prior negative or inconclusive PSMA-ligand PET/CT
Secondary outcomes (4)
- measure
- Region level detection rate
- timeFrame
- From enrollment to the end of observation at 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is male and aged \>18 years old. * Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and/or androgen deprivation therapy \[ADT\]. * An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL and within the total range of 0.2 and 2 ng/ml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng/mL and within the total range of 2 and 4 ng/ml Exclusion Criteria: * Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements. * Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist/antagonist, and first-/second-generation anti androgen alone or combined with LHRH agonist/antagonist.
References
Publications (0)
Data not yet available
No reference posted for this study.