Clinical trial · Observational
Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy
Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) PET/CT Utilizing the High Resolution Digital Philips Vereos Scanner, in Patients With Biochemical Recurrence After Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy of Axumin and resultant lack of interest in recruitment. FDA approval of PSMA also hampered enrollment.
Summary
Brief summary (as posted)
Fluciclovine F18 (Axumin) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies. Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s). 20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml. The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy. The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy. The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy). The aim is to compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluciclovine PET/CT using a digital PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group
- description
- All patients receiving SOC imaging and Axumin PET scans.
- interventionNames
- Diagnostic Test: Fluciclovine PET/CT using a digital PET/CT
Primary outcomes (1)
- measure
- Detection rate
- timeFrame
- Patients will be scheduled for both SOC imaging as well as the Fluciclovine PET within 4 weeks of screening and signing of informed consent. The detection rates between SOC and Fluciclovine scans will be compared.
- description
- Comparison of Fluciclovine digital PET/CT with standard of care imaging. Single time point.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Prostatectomy patients with previously undetectable PSA and subsequent biochemical recurrence defined by PSA between 0.2 ng/ml and 1.0 ng/ml within 90 days prior to Fluciclovine scan 2. Age \>40 3. Ability to provide informed consent Exclusion Criteria: 1. History of allergic reaction to Fluciclovine 2. Anti Androgen treatment in the 6 months prior to enrollment 3. Any patient whose body habitus, as determined by radiology personnel, will effectively inhibit the ability to obtain PET/CT imaging or will interfere with the images so as to make them clinically uninterpretable.
References
Publications (13)
- BACKGROUNDSchuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19. PMID 24144687
- BACKGROUNDOdewole OA, Oyenuga OA, Tade F, Savir-Baruch B, Nieh PT, Master V, Chen Z, Wang X, Jani AB, Bellamy LM, Halkar RK, Goodman MM, Schuster DM. Reproducibility and reliability of anti-3-[(1)(8)F]FACBC uptake measurements in background structures and malignant lesions on follow-up PET-CT in prostate carcinoma: an exploratory analysis. Mol Imaging Biol. 2015 Apr;17(2):277-83. doi: 10.1007/s11307-014-0797-1. PMID 25281411
- BACKGROUNDSchuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14. PMID 21493787
- BACKGROUNDOdewole OA, Tade FI, Nieh PT, Savir-Baruch B, Jani AB, Master VA, Rossi PJ, Halkar RK, Osunkoya AO, Akin-Akintayo O, Zhang C, Chen Z, Goodman MM, Schuster DM. Recurrent prostate cancer detection with anti-3-[(18)F]FACBC PET/CT: comparison with CT. Eur J Nucl Med Mol Imaging. 2016 Sep;43(10):1773-83. doi: 10.1007/s00259-016-3383-8. Epub 2016 Apr 18. PMID 27091135
- BACKGROUNDNanni C, Zanoni L, Pultrone C, Schiavina R, Brunocilla E, Lodi F, Malizia C, Ferrari M, Rigatti P, Fonti C, Martorana G, Fanti S. (18)F-FACBC (anti1-amino-3-(18)F-fluorocyclobutane-1-carboxylic acid) versus (11)C-choline PET/CT in prostate cancer relapse: results of a prospective trial. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1601-10. doi: 10.1007/s00259-016-3329-1. Epub 2016 Mar 10.