Clincosm LogoSign in Get a demo

F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

Sponsor
Andrei Iagaru (Other)
Overall Status
No longer available
CT.gov ID
NCT03501940
Collaborator
(none)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Radiation: Fluorine F 18 DCFPyL
  • Other: Laboratory Biomarker Analysis
  • Procedure: Positron Emission Tomography

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Expanded Access
Official Title:
18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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)

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304

    Sponsors and Collaborators

    • Andrei Iagaru

    Investigators

    • Principal Investigator: Andrei Iagaru, Stanford Cancer Institute Palo Alto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03501940
    Other Study ID Numbers:
    • IRB-42701
    • NCI-2018-00479
    • PROS0083
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Adenocarcinoma
    Fluorides

    Study Results

    No Results Posted as of Jan 21, 2022