Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

This is a multi-reader methodological study comparing the diagnostic value of
68Ga-PSMA-HBED-CC PET/CT or 68Ga-PSMA-HBED-CC PET/MRI over MRI alone, using histologic
confirmation or serial follow-up for up to 2 years as the gold standard for determination of
primary prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that
this will demonstrate the superiority of 68Ga-PSMA-HBED-CC PET to MRI for sensitivity, and
the non-inferiority of 68Ga-PSMA-HBED-CC PET to MRI for specificity.This is a paired,
case-control design that is appropriate to statistically evaluate the difference in
sensitivity and specificity between the two imaging modalities. Therefore, the estimation of
population prevalence is not a study objective, and estimation of clinical utility through
calculation of positive and negative predictive values is not appropriate. Imaging studies
and follow up subject scans will be organized so that a panel of independent readers will
evaluate the MRI and PET studies to assess the level of suspicion for prostate cancer.

1. Male aged 21 years or older.

2. Ability to provide signed informed consent and willingness to comply with protocol
requirements.

3. Pathologic confirmation of adenocarcinoma of the prostate gland or high clinical
suspicion (PSA > 4 ng/mL, or PSA density > 0.15 ng/mL2, or PSA doubling time < 2
years).

4. Meet one of the following 5 criteria

1. Planned for surgical extirpation, which may or may not include lymph node
dissection (high risk primary disease)

2. Planned for targeted biopsy of primary lesion

3. Conventional imaging equivocal or suggestive of prostate cancer metastasis/es

4. Planned focal therapy (with or without radiation therapy) with serial follow-up

5. Elevated PSA with no conventional imaging suggestive of metastatic or recurrent
disease

5. a. If part of PET/MRI cohort, subject will undergo clinically indicated MRI imaging
prior to treatment.

Or b. If part of PET/CT cohort, subject will have had clinically indicated MRI within
3 months prior to treatment.

6. Participants must agree to use an acceptable form of birth control throughout the
study period. Participants must use condoms for a period of seven days after each
injection, if engaged in sexual activity.

Exclusion Criteria:

1. Clinical and/or technical factors that would compromise statistical analysis of the
PET and/or MRI.

2. If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a
prescribed abdomen and pelvis MRI

3. If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have
a prescribed pelvis MRI

4. If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR
imaging of abdomen and pelvis

5. If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous
MR imaging of pelvis

6. If part of PET/CT cohort, investigator review determines that previous MR images do
not meet institutional quality standards

7. If part of PET/MRI cohort, contraindications to MRI

8. Contraindications to PSMA IV administration

9. Other unspecified reasons that, in the opinion of investigators, make the subject
unsuitable for enrollment