Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 Imaging in Patients with Prostate Cancer

The primary objective is to evaluate the safety and dosimetry of 68Ga-OncoACP3 imaging in patients diagnosed with prostate cancer. This evaluation is clinically significant for determining the radiation dose distribution and tolerability of the radiopharmaceutical in individuals with suspected metastasis, confirmed recurrence based on elevated prostate-specific antigen levels, or metastatic disease potentially eligible for 177Lu-labelled PSMA ligands therapy. Trial scope: 4, 6.

The sponsor did not provide information regarding the total number of participants. The study population consists of males within specific age ranges. The cohort includes individuals diagnosed with prostate cancer who present with suspected metastasis and are eligible for initial definitive therapy. Additional participants include those with suspected recurrence characterized by an elevated serum prostate-specific antigen level exceeding 0.2 ng/mL. The population also encompasses patients with metastatic disease who may be candidates for treatment utilizing 177Lu-labelled PSMA ligands.

This Phase I study is designed to evaluate the safety and dosimetry of imaging using 68Ga-OncoACP3 in individuals with prostate cancer. The research involves patients with suspected metastasis who are candidates for initial definitive therapy, suspected recurrence based on elevated serum prostate-specific antigen levels, or metastatic disease potentially eligible for treatment with 177Lu-labelled PSMA ligands. The clinical trial procedures include a screening visit to determine eligibility, followed by scheduled study visits to assess the investigated imaging agent. The total duration of the study is estimated to conclude by February 2027.

Efficacy assessment in this study involves the evaluation of patients with prostate cancer. Specifically, monitoring focuses on individuals with suspected metastasis, those with suspected recurrence indicated by an elevated serum prostate-specific antigen level, or patients with metastatic disease who are candidates for treatment with 177Lu-labelled PSMA ligands.