NCT03501940

Brief Summary

This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

First QC Date

April 10, 2018

Last Update Submit

January 6, 2022

Conditions

Prostate AdenocarcinomaPSA Level Greater Than 0.2PSA Level Greater Than or Equal to TwoPSA ProgressionRecurrent Prostate Carcinoma

Interventions

Computed TomographyPROCEDURE

Undergo 18F-DCFPyL PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Fluorine F 18 DCFPyLRADIATION

Given IV

Also known as: 18F-DCFPyL
Laboratory Biomarker AnalysisOTHER

Correlative studies

Positron Emission TomographyPROCEDURE

Undergo 18F-DCFPyL PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven prostate adenocarcinoma
  • 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)

You may not qualify if:

  • Unable to provide informed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • 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.

    PMID: 33674398DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acidMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Andrei Iagaru

    Stanford Cancer Institute Palo Alto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

US(1)