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

Phase

N/A

Condition

Prostate Disorders

Neoplasms

Prostate Cancer

Treatment

N/A

Clinical Study ID

NCT06859203

2024-643-S-NP

Ages > 18
Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient is male and aged >18 years old.
Patient with a history of localized adenocarcinoma of the prostate with priorcurative intent treatment, experiencing BCR of hormone sensitive PCa, followingprior treatment with one or more of the following: a) RP, b) RP plus adjuvanttherapy, c) RT and/or androgen deprivation therapy [ADT].
An elevated PSA, clinically suspicious for biochemically recurrent disease, thatmeets one of the following conditions: 1) Following RP with or without adjuvanttherapy: PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mLand within the total range of 0.2 and 2 ng/ml. PSA must be measured at least 6 weeksafter RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as theprimary treatment: nadir +2 ng/mL and within the total range of 2 and 4 ng/ml

Exclusion

Exclusion Criteria:

Patients with any medical condition or circumstance (including receiving aninvestigational product) that the investigator believes may compromise the datacollected or lead to a failure to fulfill the study requirements.
Current or recent androgen deprivation therapy (ADT) within 3 months prior to thestart of the study, which includes surgical orchidectomy, continuous or intermittentLHRH agonist/antagonist, and first-/second-generation anti androgen alone orcombined with LHRH agonist/antagonist.

Study Design

March 01, 2025

December 31, 2027

Study 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.

Connect with a study center

University Hospital Augsburg
Augsburg, Bavaria 86156
Germany
Site Not Available
TUM University Hospital
Munich, Bavaria 81675
Germany
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.