F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer
NCT ID: NCT03501940
Last Updated: 2022-01-21
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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Brief Summary
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Detailed Description
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I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).
OUTLINE:
Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL.
After completion of study, participants are followed up at 24-72 hours.
Conditions
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Interventions
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Computed Tomography
Undergo 18F-DCFPyL PET/CT
Fluorine F 18 DCFPyL
Given IV
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo 18F-DCFPyL PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
* Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
* PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy
* Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
* Post-radiation therapy - American Society for Radiation Oncology (ASTRO) - Phoenix consensus definition
* A rise of PSA measurement of 2 or more ng/mL over the nadir
* Able to provide written consent
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)
Exclusion Criteria
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
18 Years
ALL
No
Sponsors
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Andrei Iagaru
OTHER
Responsible Party
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Andrei Iagaru
Associate Professor of Radiology
Principal Investigators
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Andrei Iagaru
Role: PRINCIPAL_INVESTIGATOR
Stanford Cancer Institute Palo Alto
Locations
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Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Countries
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References
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Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.
Other Identifiers
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NCI-2018-00479
Identifier Type: REGISTRY
Identifier Source: secondary_id
PROS0083
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-42701
Identifier Type: -
Identifier Source: org_study_id
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