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

Metastatic Prostate Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes. ;

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03585114
• Study type: Interventional
• Source: Columbia University
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 11, 2018
• Completion date: December 2022