Clinical Trial · NCT03739684

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

Overview

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Sponsor

Progenics Pharmaceuticals

Phase

Phase 3

Contacts

Jessica D Jensen (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03739684

Drug / Compound

DCFPyL

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association \[AUA\]); or
Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology \[ASTRO\]-Phoenix)
Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
Life expectancy ≥6 months as determined by the investigator

Exclusion

Treatment with ADT in the past 3 months of Day 1
Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
Receipt of investigational therapy for prostate cancer within 60 days of Day 1
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer