Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Study Details
Study Description
Brief Summary
This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11).
The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF).
The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histopathological proven prostate adenocarcinoma
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Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL
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Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA
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Ability to understand a written informed consent document and the willingness to sign it
Exclusion Criteria:
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Current investigational therapy for prostate cancer
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Unable to lie flat, still, or tolerate a PET/CT scan
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Morand Piert, MD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00198146