Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
- Conditions
- Prostate Adenocarcinoma
- Registration Number
- NCT05415228
- Lead Sponsor
- Morand Piert, MD
- 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.
- 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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Male
- Target Recruitment
- Not specified
- Histopathological proven prostate adenocarcinoma
- 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
- 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
- Ability to understand a written informed consent document and the willingness to sign it
- Current investigational therapy for prostate cancer
- Unable to lie flat, still, or tolerate a PET/CT scan
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method