Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

This is a multi-center, multi-reader, open-label trial, comparing 99mTc-MIP-1404 SPECT/CT
imaging in men who have had a diagnostic trans-rectal ultrasound (TRUS) guided biopsy with a
histopathologic finding of Gleason score ≤3+4 who are candidates for active surveillance and
are undergoing routine biopsy or voluntary RP with or without a pelvic lymph node dissection
(PLND). This study will evaluate the sensitivity and specificity of 99mTc-MIP-1404 SPECT/CT
image assessments to correctly identify subjects with previously unknown clinically
significant prostate cancer in two cohorts: (1) Low grade prostate cancer who have elected to
undergo RP [Cohort A]; and (2) very low risk (VLR) prostate cancer per 2016 NCCN Guidelines
who are scheduled to undergo routine prostate biopsy [Cohort B].

Subjects will receive a single dose of 99mTc-MIP-1404 Injection (study drug) followed by
whole body planar and SPECT/CT (pelvic) imaging 3-6 hours after injection. In accordance with
standard of care procedures, subjects will undergo either voluntary RP [Cohort A] or prostate
biopsy [Cohort B] within 42 days after study drug dosing. 99mTc-MIP-1404 image data will be
collected by a central imaging core laboratory and evaluated for visible uptake within the
prostate gland. These findings will then be compared against central histopathology as the
truth standard. The central imaging core lab independent readers for the SPECT/CT scans will
be blinded to all clinical data, including pathology results. Likewise, central pathologists
are to remain blinded to all clinical data, including imaging results.

INCLUSION CRITERIA:

- Ability to provide informed consent and willingness to comply with protocol
requirements

- Life expectancy ≥ 6 months

Cohort A only:

- A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of
enrollment showing adenocarcinoma of the prostate gland

- Within 90 days of consent, serum PSA ≤ 15.0 ng/mL or ≤ 7.5 ng/mL if on 5 α-reductase
inhibitors.

- Candidates for active surveillance and/or a Gleason score ≤3+4

- Scheduled to undergo radical prostatectomy (RP) with or without pelvic lymph node
dissection (PLND)

Cohort B only:

- Very low risk (VLR) prostate cancer defined by 2016 NCCN Guideline criteria:

- T1c stage, and

- PSA < 10 ng/mL, and

- Gleason score ≤ 6 with < 3 biopsy cores cancer positive and ≤ 50% cancer in any core
based on prior prostate biopsy within 24 months of enrollment, and

- PSA density < 0.15 mg/mL/g

- Scheduled to undergo a reassessment of prostate cancer staging that includes prostate
biopsy as part of routine follow-up

EXCLUSION CRITERIA:

1. Subjects administered a radioisotope within 5 physical half-lives prior to study drug
injection.

2. Previous treatment with hormonal therapy, surgery (except biopsy), radiation therapy,
LHRH analogs, and non-steroidal anti-androgens, for the treatment of prostate cancer
or benign prostatic hyperplasia (BPH)

3. Planned androgen or anti-androgen therapy prior to RP surgery or biopsy

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

5. Malignancy (not including curatively treated basal or squamous cell carcinoma of the
skin) within the previous 5 years. (Ta stage transitional cell carcinoma bladder
cancer with negative surveillance cystoscopy within the past 2 years may be included).