Clinical trial · Interventional
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Laser Focal Therapy of Intermediate Risk Localized Prostate Cancer
NCT03373006CI-TRIAL-00058723completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axumin PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Men with Gleason Score 7 prostate cancer
- description
- Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.
- interventionNames
- Drug: Axumin PET/CT
Primary outcomes (1)
- measure
- Detection of Metastases
- timeFrame
- One day
- description
- Number of patients with detection of metastasis Secondary Outcome Measure Description: Number of patients with local uptake of Axumin
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male, 45 years of age or older. 2. Diagnosis of prostate adenocarcinoma. 3. Clinical stage T1a, T1b, T1c, T2a, T2b orT2c. 4. Gleason score of 7 (3+4 or 4+3). 5. PSA density less than 0.375. 6. One, two, or three tumor suspicious regions identified on multiparametric MRI. 7. Negative radiographic indication of extra-capsular extent. 8. Karnofsky performance status of at least 70. 9. Estimated survival of 5 years or greater, as determined by treating physician. 10. Tolerance for anesthesia/sedation. 11. Ability to give informed consent. Exclusion Criteria: 1. Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. 2. Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf) 3. History of other Primary non-skin malignancy within previous three years. 4. Diabetes. 5. Smoker.
References
Publications (5)
- BACKGROUNDNanni C, Schiavina R, Brunocilla E, Boschi S, Borghesi M, Zanoni L, Pettinato C, Martorana G, Fanti S. 18F-Fluciclovine PET/CT for the Detection of Prostate Cancer Relapse: A Comparison to 11C-Choline PET/CT. Clin Nucl Med. 2015 Aug;40(8):e386-91. doi: 10.1097/RLU.0000000000000849. PMID 26053708
- BACKGROUNDSchreibmann E, Schuster DM, Rossi PJ, Shelton J, Cooper S, Jani AB. Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):206-13. doi: 10.1016/j.ijrobp.2016.04.023. Epub 2016 Apr 30. PMID 27511856
- BACKGROUNDJambor I, Kuisma A, Kahkonen E, Kemppainen J, Merisaari H, Eskola O, Teuho J, Perez IM, Pesola M, Aronen HJ, Bostrom PJ, Taimen P, Minn H. Prospective evaluation of 18F-FACBC PET/CT and PET/MRI versus multiparametric MRI in intermediate- to high-risk prostate cancer patients (FLUCIPRO trial). Eur J Nucl Med Mol Imaging. 2018 Mar;45(3):355-364. doi: 10.1007/s00259-017-3875-1. Epub 2017 Nov 16. PMID 29147764
- BACKGROUNDZarzour JG, Galgano S, McConathy J, Thomas JV, Rais-Bahrami S. Lymph node imaging in initial staging of prostate cancer: An overview and update. World J Radiol. 2017 Oct 28;9(10):389-399. doi: 10.4329/wjr.v9.i10.389. PMID 29104741
- BACKGROUNDMiller MP, Kostakoglu L, Pryma D, Yu JQ, Chau A, Perlman E, Clarke B, Rosen D, Ward P. Reader Training for the Restaging of Biochemically Recurrent Prostate Cancer Using 18F-Fluciclovine PET/CT. J Nucl Med. 2017 Oct;58(10):1596-1602. doi: 10.2967/jnumed.116.188375. Epub 2017 Apr 6. PMID 28385791