Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
NCT ID: NCT05415228
Last Updated: 2023-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.
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Detailed Description
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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.
Conditions
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Interventions
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68Ga-PSMA-11
68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to lie flat, still, or tolerate a PET/CT scan
18 Years
MALE
No
Sponsors
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Morand Piert, MD
OTHER
Responsible Party
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Morand Piert, MD
Professor of Radiology
References
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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 Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29.
Other Identifiers
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HUM00198146
Identifier Type: -
Identifier Source: org_study_id
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