Prostate Specific Membrane Antigen (PSMA) PET Expanded Access Program

About the Program

  • PSMA (or prostate specific membrane antigen) is a protein found on most prostate cancers.
  • A PET scan uses a special camera to detect energy given off from radioactive material to make detailed pictures of areas where the material 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.
  • 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 program, we will be using Gallium-68 PSMA PET imaging.
  • Previously, the researchers collected data from study participants to determine the ability of 68Ga-PSMA-11 to detect the presence of prostate cancer metastasis. However, research studies at UCSF using 68Ga-PSMA-11 have ended, and the data has been submitted to the FDA for approval.
  • The 68Ga-PSMA-11 imaging agent is not yet approved by the Food and Drug Administration (FDA). While our imaging agent application is under review, the FDA is allowing you to receive investigational Gallium-68 PSMA PET imaging as a part of an Expanded Access Program (EAP) because it may help detect if your prostate cancer has spread. EAP participants must still formally enroll.

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

Enrollment Process

1)  Interested participants will need to be referred by their doctor to this study

  1. Current UCSF patients will be referred by their UCSF providers
    1. In order for us to contact the patient after an order has been placed, please email [email protected] with:
      1. Patient’s name
      2. MRN
      3. Name of the referring provider
  2. Non-UCSF patients must email [email protected] (preferred) or call 415-514-PSMA or expressing interest in the study to be added to our waitlist
    1. Documents needed from external patients:
      1. Referring provider’s order for a PSMA PETCT or PSMA PETMRI scan
      2. Most recent PSA value
      3. Pathology report with documented Gleason score
      4. Recent oncology or urology progress note

2)  Interested participants will be assigned to a Clinical Research Coordinator (CRC)

  1. CRC will call the interested participant to give background on the expanded access program and schedule a time to consent the patient into our program

3)  After being consented, the participant’s eligibility will be assessed

4)  If the participant is eligible, the participant will be

  1. enrolled into the program
  2. scheduled

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