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ACTIVE NOT RECRUITING
NCT03585114
PHASE2

Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

Primary Objective: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. Secondary Objectives: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS) * To determine whether baseline SUVmax correlate with rPFS * To compare number of lesions detected with standard imaging at baseline and at the time of progression

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2018-12-11

Completion Date

2022-12

Last Updated

2022-05-11

Healthy Volunteers

No

Interventions

DRUG

[F-18] DCFPyL

\[18F\]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of \[18F\]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).

PROCEDURE

PET/CT imaging

As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States