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

Morand Piert, MD

Status

Conditions: Prostate Adenocarcinoma

Treatments: Drug: 68Ga-PSMA-11

Study type: Expanded Access

Funder types: Other

Identifiers

NCT05415228

HUM00198146

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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