Prostate Specific Membrane Antigen (PSMA) Clinical Research Trial

About the Study

  • PSMA (or prostate specific membrane antigen) is a protein found on most prostate cancers. 68Ga-PSMA-11, also known as 68Ga-PSMA HBED-CC, is an imaging agent that binds to prostate cancer cells and can be imaged using a PET (Positron Emission Tomography) scanner. In this study, we will be testing Gallium-68 PSMA PET imaging.    
  • A PET scan uses a special camera to detect energy given off from radioactive material to make detailed pictures of areas where the Ga-68 accumulates in the body. When combined with an MRI or CT scan, the PET scan helps to more accurately map the location of where in the body the radioactive material has collected.
  • The researchers are conducting this study to help us determine the ability of 68Ga-PSMA-11 to detect the presence of prostate cancer metastasis.
  • The 68Ga-PSMA-11 imaging agent is not approved by the Food and Drug Administration (FDA). Because of this, patients who would like to undergo a PET scan using the 68GA-PSMA-11 must go through our enrollment process to participate in the PSMA Clinical Research Trial.

Enrollment Process

Patients will be referred to this study

  • UCSF patients will be referred by their UCSF providers
  • Non-UCSF patients must call 415-514-PSMA or email [email protected] expressing interest in the study to be added to our waitlist
    • Documents needed from external patients
      • Order for PSMA PETCT or PETMRI scan
      • Most recent PSA value
      • Pathology report with documented Gleason score
      • Recent oncology or urology progress note

Patients will be assigned to a clinical research coordinator (CRC)

  • CRC will call patient to give background on the clinical trial and schedule a time to consent the patient into our study

After being consented into the clinical trial, the patient is enrolled and confirmation of eligibility will be completed.

Eligibility

Inclusion Criteria

  • Male, age ≥ 18
  • Histopathologically proven prostate adenocarcinoma
  • Concern for metastatic disease in one of the following settings
    • Initial staging with intermediate to high risk prostate cancer
    • Biochemical recurrence after initial therapy

Exclusion Criteria

  • Patient unlikely to comply with study procedures, restrictions, and requirements, and is judged by the investigator to be unsuitable for study participation

Screening (must be completed within 90 days of Imaging Visit)

  • PSA - Prostate Specific Antigen

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