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

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• PSA Level Greater Than 0.2
• PSA Level Greater Than or Equal to Two
• PSA Progression
• Recurrent Prostate Carcinoma

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,