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

A Phase 2 Comparison Study of 68Ga-PSMA-HBED-CC Positron Emission Tomography (PET)/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.

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