NCT06859203

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 94 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The REFINE study is a prospective, bicentric observational trial conducted at two specialized nuclear medicine centers in Germany to evaluate the technical performance of fluciclovine (18F) PET/CT imaging in a real-world clinical setting. Patients with prostate cancer recurrence after definitive treatment who previously underwent a negative or inconclusive PSMA PET/CT are enrolled and observed for 12 months. Each participant undergoes a fluciclovine PET/CT scan as part of their normal clinical routine, with all images pseudonymized and stored in a central database where three independent nuclear medicine physicians, blinded to the local site's interpretation, review each scan. In addition to the initial imaging, follow-up assessments are conducted at one month and 12 months to validate scan findings; a questionnaire sent to the referring physician at one month helps capture any changes in the intended treatment plan, while comprehensive follow-up data-including additional imaging studies, PSA levels, treatment outcomes, and histopathological findings when available-are collected at 12 months. This follow-up information serves as a composite reference standard to distinguish true positive lesions from false positives, with criteria based on changes in lesion size, response to treatment, and confirmatory imaging or biopsy results, as well as to identify any false negatives.

Conditions

• Biochemical Recurrence of Malignant Neoplasm of Prostate

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-05
• Last updated: 2025-03-05

Locations

2 sites across 1 country: Germany