NCT03373006 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Jambor I, Kuisma A, Kähkönen E, Kemppainen J, Merisaari H, Eskola O, Teuho J, Perez IM, Pesola M, Aronen HJ, Boström PJ, Taimen P, Minn H
Prospective evaluation of (18)F-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.
Miller 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 (18)F-Fluciclovine PET/CT. J Nucl Med. 2017 Oct;58(10):1596-1602. doi: 10.2967/jnumed.116.188375. Epub 2017 Apr 6.
Nanni 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.
Schreibmann 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. Erratum in: Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):231.
Zarzour 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. Review.

A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Laser Focal Therapy of Intermediate Risk Localized Prostate Cancer

Details for clinical trial NCT03373006

Clinical trial NCT03373006 - References