Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

The study is an open label, non-randomized study designed to evaluate the diagnostic
performance of SPECT CT. The study will consist of 3 cohorts, and a subset of the patients in
cohort C will participate in a test-retest study, where the baseline SPECT/CT will be
repeated.

SPECT CT will be performed in all cohorts.

Cohort A will evaluate SPECT CT by comparison to a Positron Emission Tomography (PET) scan
using NaF.

Cohort B will evaluate SPECT CT by comparison to 18F-DCFPyL PET/CT.

Cohort C will evaluate SPECT CT by comparison to Whole Body Magnetic Resonance Imaging
(WB-MRI).

Eligible subjects will be enrolled in a non-randomized manner per the treating physician
discretion.

Inclusion Criteria:

Males ≥18 years of age. Subjects provide signed informed consent and confirm that they are
able and willing to comply with all protocol requirements.

Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant
prostate cancer (mCRPC) with Bone metastases as manifested by one or more lesions on bone
scan.

Documented castrate level of serum testosterone (≤50 ng/dl).

Documented progressive mCRPC based on at least one of the following criteria:

1. PSA progression defined as 25% increase over baseline value or nadir.

2. Radiographic progression for soft tissue lesions as per Response Evaluation Criteria
in Solid Tumors (RECIST 1.1), and/ or radiographic progression for bone lesions as
determined by radionuclide bone scan using the consensus guidelines of the PCWG3
criteria.

Planning to receive first line novel hormonal therapy with Abiraterone or Enzalutamide for
the first time for mCRPC within 4 weeks of documented progression. Baseline scans will be
obtained prior to starting new therapy.

Exclusion Criteria:

Subjects who are unable to give valid informed consent Subjects who are unwilling or unable
to undergo an SPECT, PET or MR exam, including subjects with contra-indications to MR
exams.

Subjects with prior Enzalutamide and Abiraterone for mCRPC Subjects with prior taxane
chemotherapy for mCRPC Subjects administered any radioisotope within five physical
half-lives or any IV X-ray contrast medium within 24 hours or any high density oral
contrast medium (oral water contrast is acceptable) within 5 days prior to study drug
injection.

Subjects with any medical condition or other circumstances that, in the opinion of the
investigator, compromise obtaining reliable data, achieving study objectives, or
completion.

Patients with a history reaction to gadolinium contrast agent. For cohort C, patients with
renal failure (eGFR < 60ml/min/1.73m2) or patients on dialysis.