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

Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04377152
Enrollment
Unknown
Registered
2020-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate, Prostate Adenocarcinoma, Prostate Cancer

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.

Interventions

DRUG68Gallium-PSMA-11

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).

PROCEDUREPositron Emission Tomography (PET)

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

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026