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

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ClinicalTrials.gov Identifier: NCT03501940
Expanded Access Status : Available
First Posted : April 18, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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
Prostate Adenocarcinoma PSA Level Greater Than 0.2 PSA Level Greater Than or Equal to Two PSA Progression Recurrent Prostate Carcinoma Procedure: Computed Tomography Radiation: Fluorine F 18 DCFPyL Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography

Detailed Description:

PRIMARY OBJECTIVES:

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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Procedure: Computed Tomography
    Undergo 18F-DCFPyL PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • Radiation: Fluorine F 18 DCFPyL
    Given IV
    Other Name: 18F-DCFPyL
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Positron Emission Tomography
    Undergo 18F-DCFPyL PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501940


Contacts
Contact: Jordan Cisneros (650)-725-6409 jordan.cisneros@stanford.edu

Locations
United States, California
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Contact: Andrei Iagaru    650-725-4711    aiagaru@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Andrei Iagaru
Investigators
Principal Investigator: Andrei Iagaru Stanford Cancer Institute Palo Alto

Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT03501940     History of Changes
Other Study ID Numbers: PROS0083
NCI-2018-00479 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PROS0083 ( Other Identifier: Stanford Cancer Institute Palo Alto )
IRB-42701 ( Other Identifier: Stanford IRB )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type