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

Andrei Iagaru

Status

Conditions: PSA Level Greater Than or Equal to Two; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; PSA Level Greater Than 0.2; PSA Progression

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Computed Tomography; Radiation: Fluorine F 18 DCFPyL; Procedure: Positron Emission Tomography

Study type: Expanded Access

Funder types: Other

Identifiers

NCT03501940

IRB-42701

PROS0083 (Other Identifier)

NCI-2018-00479 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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