Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer With Biochemical Recurrence

Inclusion Criteria (Cohort 1):

- Male ≥ 18 years of age

- Prostate cancer patients presenting with rising PSA after radical prostatectomy for
treatment if primary disease.

- PSA ≥ 0.2 ng/mL

- Patients must give informed consent for the research study, and agree to allow
investigator access to clinical results following treatment plan implementation such
as description of the treatment plan and PSA values following implementation of
treatment plan as part of standard care, typically determined 3-4 months after
treatment.

Inclusion Criteria (Cohort 2):

- Male ≥ 18 years of age

- Histologically confirmed prostate cancer with following Gleason scoring at biopsy:

- Gleason ≥ 4+3 OR

- Gleason 3+4 with >30% pattern 4 or ≥3 cores positive

- Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)

- Patients must give informed consent for the research study, and agree to allow
investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for
surgical planning if done, or biopsy data following prostatectomy including lymph node
dissection biopsy data, if available.

Exclusion Criteria (Cohorts 1& 2):

- Inability to give informed consent.

- Patient is unable to tolerate remaining still on the bed of the PET camera, due to
physical limitations or claustrophobia.

- Significant acute or chronic medical, neurologic, or illness in the subject that, in
the judgment of the Clinical Investigators, could compromise subject safety, limit the
ability to complete the study, and/or compromise the objectives of the study