NCT04509557 - 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)

Haberkorn U, Eder M, Kopka K, Babich JW, Eisenhut M
New Strategies in Prostate Cancer: Prostate-Specific Membrane Antigen (PSMA) Ligands for Diagnosis and Therapy. Clin Cancer Res. 2016 Jan 1;22(1):9-15. doi: 10.1158/1078-0432.CCR-15-0820. Review.
Lütje S, Heskamp S, Cornelissen AS, Poeppel TD, van den Broek SA, Rosenbaum-Krumme S, Bockisch A, Gotthardt M, Rijpkema M, Boerman OC
PSMA Ligands for Radionuclide Imaging and Therapy of Prostate Cancer: Clinical Status. Theranostics. 2015 Oct 18;5(12):1388-401. doi: 10.7150/thno.13348. eCollection 2015. Review.
Maurer T, Eiber M, Schwaiger M, Gschwend JE
Current use of PSMA-PET in prostate cancer management. Nat Rev Urol. 2016 Apr;13(4):226-35. doi: 10.1038/nrurol.2016.26. Epub 2016 Feb 23. Review.
Mease RC, Foss CA, Pomper MG
PET imaging in prostate cancer: focus on prostate-specific membrane antigen. Curr Top Med Chem. 2013;13(8):951-62. Review.
Zhou J, Neale JH, Pomper MG, Kozikowski AP
NAAG peptidase inhibitors and their potential for diagnosis and therapy. Nat Rev Drug Discov. 2005 Dec;4(12):1015-26. Review.

[177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer: Phase I Clinical Trial.

Clinical trial NCT04509557 - References