Status:
NO_LONGER_AVAILABLE
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Lead Sponsor:
Morand Piert, MD
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
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 cl...
Eligibility Criteria
Inclusion
- 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
- Current investigational therapy for prostate cancer
- Unable to lie flat, still, or tolerate a PET/CT scan
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05415228
Last Update
May 18 2023
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