A Prospective Phase 2/3, Multicenter, Open Label Study of [68Ga]- LNTH2401 PET/CT Imaging in Participants With Prostate Cancer: Phase 2 Dose Optimization in Either Newly Diagnosed or Biochemically Recurrent Prostate Cancer and Phase 3 Diagnostic Performance in Participants Who Are Newly Diagnosed and Have at Least High Risk or Suspected Metastatic Disease and Planning to Undergo Radical Prostatectomy Plus Pelvic Lymph Node Dissection (SPARROW)

Summary

This is an open-label, nonrandomized, multicenter study conducted in two sequential parts: an initial Phase 2 Dose Optimization Period followed by the Phase 3 Diagnostic Performance Period. After the optimal administered activity and imaging time window are selected in Phase 2, Phase 3 will enroll participants with recently diagnosed PCa who are at least high risk or have suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection (RP+PLND). Safety assessments throughout the study will include monitoring of adverse events, vital signs, ECGs, and clinical laboratory parameters. Participants will be enrolled sequentially in a nonrandomized manner, with competitive enrollment across study sites.

Description