Evaluating Fluciclovine PET imaging for recurrent prostate cancer detection

Prospective Evaluation of Fluciclovine (18F) PET/CT in Patients with Prior Negative PSMA PET/CT

This study is testing if fluciclovine PET scans can help find recurrent prostate cancer in men who had unclear results from previous scans.

Quick facts

• Study type: Observational
• Enrollment: 94 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Technical University of Munich (other)
• Locations: 2 sites (Augsburg, Bavaria and 1 other locations)
• Trial ID: NCT06859203 on ClinicalTrials.gov

What this trial studies

The REFINE study is an observational trial assessing the effectiveness of fluciclovine (18F) PET/CT scans in detecting recurrent prostate cancer in patients who previously had negative or inconclusive PSMA PET/CT results. Conducted at two specialized nuclear medicine centers in Germany, the study enrolls male patients over 18 years old with a history of localized prostate adenocarcinoma and biochemical recurrence. Participants undergo fluciclovine PET/CT scans as part of their clinical routine, with follow-up assessments at one and twelve months to validate the imaging findings. The study aims to establish a reference standard for distinguishing true positive lesions from false positives based on comprehensive follow-up data.

Who should consider this trial

Good fit: Ideal candidates are males over 18 years old with a history of localized prostate cancer who have experienced biochemical recurrence after curative treatment.

Not a fit: Patients with ongoing medical conditions that may interfere with the study or those currently receiving investigational products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the detection of recurrent prostate cancer, leading to more effective treatment strategies for patients.

How similar studies have performed: Other studies have shown promise in using PET imaging for cancer detection, but this specific approach with fluciclovine PET in this context is relatively novel.

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.

Where this trial is running

Augsburg, Bavaria and 1 other locations

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

Study contacts

• Principal investigator: Matthias Eiber, MD — Technical University of Munich
• Study coordinator: Matthias Eiber, MD

Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate, prostate cancer, biochemical recurrence, PET, PSMA, fluciclovine, BCR, prostate