68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-RM2 PET/CT for detection of intermediate and high-risk prostate cancer
prior to prostatectomy.

OUTLINE:

Patients receive 68Ga-RM2 intravenously (IV). Within 45-60 minutes, patients undergo a PET/CT
scan. Patients may undergo a second PET/CT scan immediately after the first scan for
attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the
completion of their treatment to evaluate response to therapy, if requested by the treating
physician.

After completion of study, patients are followed up at 24-48 hours and within 3-12 months.

Inclusion Criteria:

- Biopsy proven prostate adenocarcinoma

- Planned prostatectomy with lymph node dissection

- Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage
[T2b or greater], Gleason score [Gleason score > 6] or other risk factors)

- Able to provide written consent

- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
[ECOG]/World Health Organization [WHO] equivalent)

- Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to
the 68Ga-RM2 PET

Exclusion Criteria:

- Inability to lie still for the entire imaging time (approximately 30 minutes)

- Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

- Any additional medical condition, serious intercurrent illness, or other extenuating
circumstance that, in the opinion of the Investigator, may significantly interfere
with study compliance