Tests a fluciclovine PET scan for prostate cancer that has returned after treatment
Checks a fluciclovine PET scan in men whose earlier PSMA scan was negative.
Plain-language title generated from the registry record
Registry title: A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET
Key facts
- Where
- Augsburg and Munich, GermanySee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men whose prostate cancer may have come back after treatment, shown by a rising PSA, and whose earlier PSMA PET/CT scan was negative or unclear.
- Age
- Over 18 years
- Sex
- Men only
- Disease stage
- Prostate cancer (adenocarcinoma) that began in the prostate only and came back after treatment, shown by a rising PSA (BCR), still sensitive to hormone therapy. After surgery, PSA is 0.2 to 2 ng/mL, confirmed twice. After radiotherapy, PSA is 2 above its lowest level and between 2 and 4 ng/mL.
- Earlier treatment
- Must have had treatment meant to remove all of the disease: prostate surgery (with or without extra therapy) or radiotherapy and/or androgen deprivation therapy (ADT). Must not have had ADT in the last 3 months.
- Biomarker or test result
- PSA must be measured at least 6 weeks after prostate surgery.
Main reasons for not taking part
- Hormone therapy (ADT) within the last 3 months
- Any condition or circumstance that the investigator believes could affect the data or the ability to follow the study
- Receiving another investigational product, if the investigator believes it could affect the data
Read by machine on 12 November 2026.
Where in Germany
- University Hospital AugsburgAugsburg, GermanyContact: Constantin Lapa, MDNot yet recruiting
- TUM University HospitalMunich, GermanyContact: Matthias Eiber, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Technical University of Munich
- Trial code
- NCT06859203
- Record updated
- 5 March 2025
- Original description
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.Read full original descriptionShow less
Prospective Evaluation of Fluciclovine (18F) PET/CT in Patients with Prior Negative PSMA PET/CT
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.
Inclusion: 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: 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.