A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET

Recruiting now

Conditions studied: Biochemical Recurrence of Malignant Neoplasm of Prostate

In brief

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.

Key facts

Study ID

NCT06859203

Run by

Technical University of Munich

People needed

94

Starts

2025-03-01

Expected to finish

2027-12-01

Last updated by the study team

2025-03-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• TUM University Hospital — Munich, Bavaria, Germany (enrolling)
• University Hospital Augsburg — Augsburg, Bavaria, Germany

Full record on ClinicalTrials.gov

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