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.
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
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.
Participants with a diagnosis of BCR and negative or inconclusive PSMA-ligand PET of previous radically treated PCa, aged ≥18 years old, eligible for fluciclovine PET/CT.
Case-only
Prospective
Not listed
Patient-level detection rate
The patient-level detection rate of fluciclovine (18F) PET/CT in patients with a prior negative or inconclusive PSMA-ligand PET/CT
Region level detection rate
Region level detection rate of fluciclovine (18F) PET/CT with prior negative or inconclusive PSMA-ligand PET/CT
Detection rate stratified by PSA level
Detection rate (patient and region level) of fluciclovine (18F) PET/CT with prior negative or inconclusive PSMA-ligand PET/CT, stratified by PSA level
Intended management change
The proportion of patients with a change of intended management after fluciclovine (18F) PET/CT
Interreader agreement
Reader kappa statistics of fluciclovine (18F) scan interpretation by the blinded independent readers
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