The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Condition: Prostate Cancer; Prostate Cancer Metastatic
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga PSMA-11 injection; Positron Emission Tomography/Computed Tomography
Intervention description: Injection of 68Ga PSMA-11; PET/CT scan after 68Ga PSMA-11 injection
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Unblinded, single arm imaging study
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PET/CT; prostate cancer; Gallium-68; PSMA-11

Summary:

      To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific
      Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to
      increase diagnostic accuracy in localizing primary and metastatic lesions in patients with
      suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS)
      scores and Prostate-Specific Antigen (PSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated
             and/or rising PSA) as determined by referring physician

          -  Patients must have had a diagnostic, standard of care mpMRI of the prostate with at
             least one lesion with a PI-RADS v2.1 score ≥ 4

          -  In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one
             PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.

          -  Patients must be scheduled for biopsy or radical prostatectomy

          -  Patients should not have had any type of curative or palliative therapy for prostate
             cancer before enrolling in the study

          -  Patients must be medically stable as judged by the patient's physician

          -  Patients must be able to lie still for a total of 60 minutes for the PET/CT scans

          -  Ability to understand and the willingness to sign a written informed consent

        Exclusion Criteria:

          -  Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot
             participate in the study

          -  Patients who have had a prior biopsy for prostate cancer cannot participate in the
             study

          -  Patients who have been treated for cancers other than skin cancers

          -  Subjects may not be receiving any other investigational agents for the treatment of
             the cancer under study

          -  Patients may not weigh more than the maximum weight limit for the PET/CT scanner table
             (>200 kilograms or 440 pounds)

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based
             intravenous contrast agent used during the mpMRI

          -  Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia
             (BPH) procedures, including steam/laser therapies