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NCT05415228 Clinical Trial

Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT05415228
Other study ID # HUM00198146
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date May 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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 information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Ga-PSMA-11
68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Morand Piert, MD

References & Publications (1)

Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Re — View Citation

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