NCT03824275

18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, \[18F\] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. 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.

Detailed description

The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT. \[18F\]DCFPyL will be used for study imaging.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	18F- DCFPyL PET/CT	A CT scan using a radioactive marker to better image tumors

Timeline

• Start date: 2019-02-12
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2019-01-31
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study