PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer

This is a prospective, single arm, phase 2 clinical trial. This patient population will have
low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. Patients
will be scheduled for magnetic resonance imaging (MRI) as part of routine care for either
surgical planning or for further biopsy. Following the informed consent process, patients who
enroll in the study will receive a PSMA positron emission tomography (PET) study along with
their standard of care (SOC) MRI on an integrated PET-MRI. Registration of PET and MRI will
be done using software to generate the PET-MRI images. Patients receiving SOC MRI guided
biopsy will receive additional PET guided biopsies as indicated in a single session. The
sensitivity and specificity will be evaluated along with the ability of the tracer to inform
the treatment planning. Patients receiving surgical removal of the prostate will have a
slice-by-slice whole mount analysis to assess the sensitivity and specificity the PSMA PET.

Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the location and
size of clinically significant prostate cancer lesions in low and intermediate risk disease.

Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.

Exploratory Objectives Generate pilot data for future larger clinical trials

Inclusion Criteria:

1. ≥ 18 years of age

2. Must provide written informed consent

3. Presence of low or intermediate risk prostate cancer (Gleason grade groups 1-3,
PSA<20) on prostate biopsy. Grade-group scoring:

1. 1 = Gleason 3 + 3

2. 2 = 3 + 4

3. 3 = 4 + 3

4. 4 = 4 + 4

5. 5 = 4 + 5, 5 + 4, or 5+5

4. Scheduled for prostate biopsy, focal treatment or surgical removal of prostate

5. Willing and able to lie still for approximately 50 minutes in an enclosed space for
the standard of care mpMRI

Exclusion Criteria:

1. Participation in another investigational trial involving research exposure to ionizing
radiation concurrently or within 30 days.

2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).

3. Significant acute or chronic medical, neurologic, or psychiatric illness in the
subject that, in the judgment of the Principal Investigator, could compromise subject
safety, limit the subject's ability to complete the study, and/or compromise the
objectives of the study.