Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

Johns Hopkins Medicine

Status

Completed

Conditions

Adenocarcinoma of the Prostate

Treatments

Drug: 18F-DCFPyL

Study type

Interventional

Funder types

Other

Identifiers

NCT02523924

J1545

IRB00062296 (Other Identifier)

Details and patient eligibility

About

This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

Full description

18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Enrollment

50 patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years
History of adenocarcinoma of the prostate treated with radical prostatectomy
Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment
Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment

Exclusion criteria

Intention to enroll in a blinded therapeutic clinical trial
History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)