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

Launched by TECHNICAL UNIVERSITY OF MUNICH · Feb 27, 2025

Keywords

ClinConnect Summary

The REFINE study is investigating whether a special type of imaging called fluciclovine PET/CT can help find recurring prostate cancer in men who previously had inconclusive or negative results from another imaging test known as PSMA PET/CT. This trial is specifically for men over 18 who have had localized prostate cancer treated with surgery or radiation and are now showing signs of recurrence, indicated by rising PSA levels (a marker for prostate cancer).

To participate in this study, men must be experiencing biochemical recurrence of their prostate cancer after prior treatment and have specific PSA levels that suggest recurrence. Participants will undergo the fluciclovine PET/CT scan to see if it can provide clearer results than their previous tests. The study is currently recruiting participants, so if you or someone you know meets the eligibility criteria, it could be a valuable opportunity to explore better detection methods for prostate cancer.

Gender

MALE

Eligibility criteria

• 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/mL and within the total range of 2 and 4 ng/ml
• Exclusion Criteria:
• • 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.