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

Sponsor
University of California, San Francisco (Other)
Overall Status
Approved for marketing
CT.gov ID
NCT04377152
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male

    Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following 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:

    4. Initial staging with intermediate to high risk prostate cancer.

    5. Biochemical recurrence after initial therapy.

    6. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Thomas Hope, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Hope, Principal Investigator, University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04377152
    Other Study ID Numbers:
    • EA-HOPE20200129
    • 20-30046
    First Posted:
    May 7, 2020
    Last Update Posted:
    Mar 1, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Mar 1, 2021