Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Primary Purpose
Prostate Adenocarcinoma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
68Ga-PSMA-11
Sponsored by
About this trial
This is an expanded access trial for Prostate Adenocarcinoma focused on measuring Prostate Cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05415228
Brief Title
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Official Title
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Morand Piert, MD
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Prostate Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-11
Other Intervention Name(s)
HBED-CC, Glu-urea-Lys(Ahx)-HBED-CC, PSMA-HBED-CC
Intervention Description
68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
34326126
Citation
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.
Results Reference
result
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Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
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