Clinical Trial · NCT03824275

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

Overview

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.

Sponsor

Jilin University

Phase

Phase 2/3

Contacts

Matthew C. Dallos, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03824275

Drug / Compound

DCFPyL

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

PSA ≥ 0.2ng/ml
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
Wiling to comply with clinical trial instructions and requirements
Histologically confirmed diagnosis of prostate cancer
Willing to cover the cost of PyL PET/CT imaging if funds are not available

Exclusion

Presence of prostate brachytherapy implants unless approved by the PI
Aspartate transaminase (AST) or alanine aminotransferase (ALT) \>5 times the upper limit of normal
Radiation or chemotherapy within 2 weeks prior to trial enrollment
Serum creatinine \> 3 times the upper limit of normal
History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
Inadequate venous access
Serum total bilirubin \> 3 times the upper limit of normal
Administration of another radioisotope within five physical half-lives of trial enrollment