A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer
The aim of this study is to assess the safety and dosimetry of imaging with \[68Ga\]Ga-OncoACP3 in patients with prostate cancer.
• Prostate cancer patients with:
‣ suspected metastasis who are candidates for initial definitive therapy
⁃ suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level \> 0.2 ng/mL)
⁃ metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer)
• Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
• Age ≥ 18
• ECOG ≤ 1
• Patient must not have any concomitant infections or active concomitant disease.
• All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤ 1.
• Life expectancy of more than 12 weeks.
• Ability to undergo imaging study procedures.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
⁃ Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.