Safety and Preliminary Diagnostic Performance of [64Cu]Cu-RAX301 in Prostate Cancer

This is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics, biodistribution, imaging characteristics, and preliminary diagnostic performance of \[⁶⁴Cu\]Cu-RAX301 Injection in patients with prostate cancer. Phase I will evaluate two administered activity levels of \[⁶⁴Cu\]Cu-RAX301 Injection in participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection (pre-RP population) and will support selection of the administered activity for Phase II. Phase II will evaluate the selected administered activity in two independent expansion cohorts: participants with suspected recurrence or biochemical recurrence of prostate cancer and participants scheduled to undergo radical prostatectomy and pelvic lymph node dissection.