Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
NCT ID: NCT03353740
Last Updated: 2021-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
346 participants
INTERVENTIONAL
2017-09-20
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Ga-68 labeled PSMA-11 PET
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Interventions
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Ga-68 labeled PSMA-11 PET
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
* Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
* PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
* Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy
* Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
* Age \>= 18.
* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
* Concomitant investigational therapy.
* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
18 Years
MALE
No
Sponsors
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Thomas Hope
OTHER
Responsible Party
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Thomas Hope
Assistant Professor
Principal Investigators
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Thomas Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Fendler WP, Calais J, Eiber M, Simko JP, Kurhanewicz J, Santos RD, Feng FY, Reiter RE, Rettig MB, Nickols NG, Kishan AU; PSMA PET Reader Group; Slavik R, Carroll PR, Lawhn-Heath C, Herrmann K, Czernin J, Hope TA. False positive PSMA PET for tumor remnants in the irradiated prostate and other interpretation pitfalls in a prospective multi-center trial. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):501-508. doi: 10.1007/s00259-020-04945-1. Epub 2020 Aug 17.
Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2018-00040
Identifier Type: REGISTRY
Identifier Source: secondary_id
175518
Identifier Type: -
Identifier Source: org_study_id