A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Neg
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.
| Condition(s) | Biochemical Recurrence of Malignant Neoplasm of Prostate |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Technical University of Munich |
| Locations | Augsburg, Bavaria, Germany; Munich, Bavaria, Germany |
| Start date | 2025-03 |
| NCT ID | NCT06859203 |
| Official listing | https://clinicaltrials.gov/study/NCT06859203 |