A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

This is an exploratory, single arm, open label pilot study evaluation of 123I-MIP-1072
intraprostatic uptake determination by SPECT/CT imaging (and optional CGCP imaging), with
histological confirmation of disease localization and staging. Methodical evaluation of
123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important
preliminary data upon which further clinical studies can be based. The optional additional
CGCP imaging was added, because of its inherent potential for higher resolution
scintigraphic detection of 123I-MIP-1072 localization. This imaging feasibility data will
provide important preliminary information for the use of CGCP imaging in prostate cancer.

Inclusion Criteria:

- Participant must be scheduled to undergo standard of care prostatectomy for presumed
localized prostate cancer at the NIH Clinical Center.

- Have had or will undergo multiparametric endorectal coil 3T MR at the NIH clinical
center

- Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence
of adenocarcinoma of the prostate gland

- Participant must be 18 years or older.

- ECOG Performance grade of 0 to 2. (see Appendix 1)

- Ability to understand and provide informed consent. All subjects must sign a document
of informed consent indicating their understanding of the investigational nature and
risks of the study before any protocol related studies are performed.

- Participants of childbearing potential must agree to use an acceptable form of birth
control, defined as abstinence, barrier or other acceptable, effective contraceptive
method until 7 days after the infusion of study drug.

Exclusion Criteria:

- Participants for whom participating would significantly delay the scheduled standard
of care therapy.

- Subjects must not have prostate biopsies performed within 12 weeks before imaging; or
within 8 weeks before imaging providing that the absence of hemorrhage is confirmed
by MR imaging.

- SGOT and SGPT ≥ 2 x of the upper limits of normal; total bilirubin, of ≥ 1.5 x the
upper limits of normal or ≥ 3.0 mg/dl in patients with Gilbert's syndrome.

- Administered a radioisotope within 5 physical half lives prior to study enrollment.

- Patients with severe claustrophobia unresponsive to oral anxiolytics

- Subjects weighing ≥350 lbs or are unable to fit within the imaging gantry

- Subjects who have received androgen deprivation therapy.

- Subjects with any medical condition or other circumstances that, in the opinion of
the Investigator, would significantly decrease obtaining reliable data, achieving
study objectives or completing the study.