PSMA Imaging of Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 89ZR-DF-IAB2M; 68Ga-PSMA-HBED-CC
Intervention description: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan; Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PET/CT; Imaging; Nuclear Medicine

Summary:

      The present study is a phase II, open label, single-center, non-randomized, single-dose
      study.

      Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.

      The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized,
      clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer
      (PCa).

      After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg
      infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.

      2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a
      Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.

      (they will also undergo a pelvic MRI if they have not obtained an MR image during the
      screening period or on day of infusion)

      Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours
      after the injection) will also be performed prior to radical prostatectomy depending on
      subject's availability and compliance.

      Patient will undergo radical prostatectomy after completion of above imaging procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed localized prostate cancer
             that are scheduled to undergo radical prostatectomy.

          -  Age >18 years.

          -  Patients must have laboratory values consistent with eligibility to undergo a radical
             prostatectomy:

               -  creatinine less than or equal to 1.5 X upper limit of normal

               -  creatinine clearance > 60 mL/min

          -  The effects of 89Zr-Df-IAB2M on the developing human fetus at the recommended
             therapeutic dose are unknown. For this reason, men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation. Should a woman become pregnant or
             suspect she is pregnant while her male partner is participating in this study, she
             should inform her treating physician immediately.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or
             investigational therapy between the time of conventional imaging, 89Zr-Df-IAB2M PET/CT
             and the surgical resection used for the study evaluation.

          -  Transrectal prostate biopsy performed less than four weeks prior to 89Zr-Df-IAB2M
             administration.

          -  Uncontrolled 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.