Evaluating Fluciclovine PET imaging for recurrent prostate cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• TUM University Hospital
  Munich, Bavaria, Germany Recruiting
• University Hospital Augsburg
  Augsburg, Bavaria, Germany Not yet recruiting

Study contacts

• Principal investigator: Matthias Eiber, MD — Technical University of Munich
• Study coordinator: Matthias Eiber, MD
• Email: matthias.eiber@tum.de
• Phone: +49 89 4140 0

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.