Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery
NCT ID: NCT03515577
Last Updated: 2020-10-14
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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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2019-04-12
2019-04-25
Brief Summary
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Detailed Description
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I. To compare the detection rates of gallium 68-labeled PSMA-11 (\[68\]Ga-PSMA-11) PET/CT and fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and region based analysis.
SECONDARY OBJECTIVES:
I. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT, stratified by prostate-specific antigen (PSA) value (0.2 - \< 0.5; 0.5 - \< 1.0; 1.0 - \< 2.0).
II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by histopathology/biopsy and/or clinical and conventional imaging follow-up.
III. Agreement among the readers, separate for (68)Ga-PSMA-11 PET/CT versus Axumin PET/CT.
OUTLINE:
Participants receive (68)Ga-PSMA-11 intravenously (IV) and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
After completion of the PET/CT scan, participants are followed up between 1 and 3 days and up to 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
Computed Tomography
Undergo PET/CT
Fluciclovine F18
Given fluciclovine F18
Gallium Ga 68-labeled PSMA-11
Given IV
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Fluciclovine F18
Given fluciclovine F18
Gallium Ga 68-labeled PSMA-11
Given IV
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radical prostatectomy as definitive treatment for PCa
* Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy
* PSA values ranging from 0.2 ng/mL to 2 ng/mL
* No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection)
* Axumin PET/CT scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11 PET/CT
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization \[WHO\] equivalent)
* 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 scan
19 Years
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Johannes Czernin, M.D.
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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References
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Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30.
Other Identifiers
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NCI-2018-00546
Identifier Type: REGISTRY
Identifier Source: secondary_id
17-001885
Identifier Type: OTHER
Identifier Source: secondary_id
17-001885
Identifier Type: -
Identifier Source: org_study_id
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