Clinical Trial · NCT04727736

18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

Overview

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

Sponsor

University of Virginia

Phase

Phase 2

Contacts

Ashok Muthukrishnan, MD, MS (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04727736

Drug / Compound

DCFPyL

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Histologically confirmed diagnosis of prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition)
Willing to comply with clinical trial instructions and requirements

Exclusion

Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC
Estimated glomerular filtration rate (eGFR) \< 15 ml/mmol
Presence of prostate brachytherapy implants unless approved by the PI
Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL.
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 total bilirubin \> 3 times the upper limit of normal