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

Primary Purpose

Prostate Cancer, Prostate, Prostate Adenocarcinoma

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
68Gallium-PSMA-11
Positron Emission Tomography (PET)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)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:

    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

Sites / Locations

  • University of California, San Francisco

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 1, 2020
Last Updated
February 24, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04377152
Brief Title
Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer
Official Title
Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer
Study Type
Expanded Access

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate, Prostate Adenocarcinoma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
68Gallium-PSMA-11
Other Intervention Name(s)
PSMA-HBED-CC
Intervention Description
PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
PET, PET Scan
Intervention Description
A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria: Inclusion Criteria: Age ≥ 18 years Histopathologically confirmed or biopsy 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hope, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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