Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: PET/MRI with Gallium-68 labeled PSMA-HBED-CC; Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC; PET/CT with Gallium-68 labeled PSMA-HBED-CC
Intervention description: Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical; Subjects have two visits (the second visit being optional) within two years. During each visit, they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical; Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
Intervention MeSH terms: Edetic Acid; N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Screening
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects may be assigned to one of three groups, each with a different intervention in terms of either mode or frequency
Masking: None (Open Label)
Enrollment: 273.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No
Keywords: prostate cancer

Summary:

      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.
    

Eligibility criteria:

        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