Actively Recruiting
A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET
Led by Technical University of Munich · Updated on 2025-03-05
94
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is male and aged >18 years old.
- History of localized adenocarcinoma of the prostate treated with curative intent.
- Experiencing biochemical recurrence of hormone sensitive prostate cancer.
- Prior treatment with radical prostatectomy, radical prostatectomy plus adjuvant therapy, radiotherapy, and/or androgen deprivation therapy.
- Elevated PSA level meeting specific criteria: after prostatectomy, PSA 10.2 ng/mL with confirmatory PSA 10.2 ng/mL within 0.2 to 2 ng/mL; after radiotherapy, PSA rise nadir +2 ng/mL within 2 to 4 ng/mL.
- PSA measurement taken at least 6 weeks after prostatectomy.
You will not qualify if you...
- Any medical condition or circumstance that could compromise data collection or study participation.
- Current or recent androgen deprivation therapy within 3 months before study start, including surgical orchidectomy, continuous or intermittent LHRH agonist/antagonist, and first- or second-generation anti-androgen therapies alone or combined with LHRH agonist/antagonist.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Hospital Augsburg
Augsburg, Bavaria, Germany, 86156
Not Yet Recruiting
2
TUM University Hospital
Munich, Bavaria, Germany, 81675
Actively Recruiting
Research Team
M
Matthias Eiber, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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