Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

Sponsor: University of California, San Francisco

Expanded Access
Approved for Marketing
Sponsor score: 40

ClinicalTrials ID:NCT04377152

This expanded access protocol offers 68Ga-PSMA-11 PET imaging for eligible prostate cancer patients, aiding in detection and localization. Participants must be 18+, with confirmed prostate adenocarcinoma and potential metastatic disease. The intervention involves a radiopharmaceutical injection and PET scan. Exclusion applies to those unable to comply with protocol requirements.

Patient Parameters

Program Overview

This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

Eligibility Criteria

Inclusion Criteria

  1. Age ≥ 18 years

  2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma.

  3. Concern for metastatic disease in one of the following settings:

    1. Initial staging with intermediate to high risk prostate cancer.
    2. Biochemical recurrence after initial therapy.

  4. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

  1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation

Locations

FACILITYZIPCITYSTATE
University of California, San Francisco94143San FranciscoCalifornia

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