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NCT03501940 Clinical Trial

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

Prostate Adenocarcinoma Clinical Trial

Official title:
18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03501940
Other study ID # IRB-42701
Secondary ID NCI-2018-00479PR
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Computed Tomography
Undergo 18F-DCFPyL PET/CT
Radiation:
• Fluorine F 18 DCFPyL
Given IV
Other:
• Laboratory Biomarker Analysis
Correlative studies
Procedure:
• Positron Emission Tomography
Undergo 18F-DCFPyL PET/CT

Locations
Country Name City State
United States Stanford Cancer Institute Palo Alto Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Andrei Iagaru

Country where clinical trial is conducted

United States, 

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