A Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer

Background:

People with prostate cancer usually have their cancer imaged with a CT scan and bone scan.
They then have their prostate gland removed. Researchers want to test a scan that might
predict if prostate cancer will return after this surgery.

Objective:

To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer
will return. Also, to test if this approach is better or worse than the usual approach for
prostate cancer.

Eligibility:

Men ages 18 and older with prostate cancer that appears to be contained within the prostate
but is at risk of having spread

Design:

Participants will be screened with:

- Medical history

- Blood tests

- CT and MRI scans: Participants will lie in a machine. The machine will take pictures of
the body.

- Bone scan

Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of
their whole body 60 90 minutes later. During the scan, they will lie on their back and stay
still.

Within 60 days after the scan, participants will have surgery. This will remove the prostate
gland and lymph nodes around it. Some tissue will be used for genetic testing.

If the PET/CT scan suggests the cancer has spread, participants may need to have another
biopsy within 60 days after the scan.

After surgery, participants will have follow-up visits for 5 years. They will have 5 visits
the first year and 2 the second. Then they will have visits once a year.

If participants cancer returns, they will have repeat PET/CT scans.

- INCLUSION CRITERIA:

- Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA
certified laboratory.

- Must have prostate cancer with high risk features defined as:

- Gleason 8 and higher OR

- PSA > 20 ng/mL OR

- Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b

- Patients must be eligible for and must be planning to undergo radical prostatectomy
and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT

- Men age greater than or equal to 18 years.

- ECOG performance status <2

- Patients must have adequate organ and marrow function as defined below:

- Hemoglobin greater than or equal to 9 g/dL

- leukocytes greater than or equal to 3,000/mcL

- platelets greater than or equal to 100,000/mcL

- total bilirubin <2 X normal institutional limits

- AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits

- creatinine <2 X normal institutional limits

OR

eGFR greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal.

- Ability of subject to understand and the willingness to sign a written informed
consent document.

- Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.

- Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT

EXCLUSION CRITERIA:

- Any investigational agents in the past 28 days prior to enrollment.

- Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).

- Distant metastatic disease on conventional imaging studies (computed tomography (CT))
of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone
scan. Given lack of specificity of CT for lymph node metastases at lower thresholds,
pelvic lymph nodes below 2 cm in the short axis are allowed.

- Any prior hormone therapy used to treat prostate cancer, except limited androgen
receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The
medication must be discontinued within 5 half-lives of the compound prior to study
entry.

- Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.

- Contraindication to MRI or PET:

- Patients weighing more than weight limit for the scanner tables or unable to fit
within the imaging gantry

- Prior reaction to 18F-DCFPyL

- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable
electronic device that are not MRI compatible at 3 T

- Severe claustrophobia unresponsive to oral anxiolytics

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Other medical conditions deemed by the principal investigator (or associates) to make
the subject unsafe/ineligible for the protocol procedures or for radical
prostatectomy.

- A malignancy within the past 3 years for which prostatectomy is a contraindication.

- Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT
imaging.

- PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of
18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium.

- Unable to refrain from fathering a child or donating sperm for 10 days after each
18FDCFPyL injection.