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

NCT03585114 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-05-11

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Matthew C. Dallos, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585114 on ClinicalTrials.gov