Prostate Adenocarcinoma
Conditions
Keywords
Prostate Cancer
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.
Interventions
DRUG68Ga-PSMA-11
68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging
Sponsors
Morand Piert, MD
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* Current investigational therapy for prostate cancer * Unable to lie flat, still, or tolerate a PET/CT scan
Outcome results
None listed