Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Peter Carroll

Description

Summary

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.

Official Title

A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

Keywords

Prostate Cancer Prostate Adenocarcinoma Prostate Cancer Recurrent Prostate Cancer Metastatic Positron emission tomography biochemical recurrence rising PSA PET/CT Diagnostic Imaging PSMA radical prostatectomy BCR Prostatic Neoplasms Adenocarcinoma Recurrence 18F-DCFPyL

Eligibility

You can join if…

Open to males ages 18 years and up

  • Male >/= 18 years of age
  • Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
  • 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)
  • 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
  • Life expectancy ≥6 months as determined by the investigator
  • Able and willing to provide informed consent and comply with protocol requirements

You CAN'T join if...

  • Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
  • Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
  • Treatment with ADT in the past 3 months of 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

Locations

  • University of California San Francisco - Helen Diller Cancer Center not yet accepting patients
    San Francisco California 94143 United States
  • Stanford not yet accepting patients
    Stanford California 94305 United States

Lead Scientist

  • Peter Carroll
    Professor, Urology. Authored (or co-authored) 447 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Progenics Pharmaceuticals, Inc.
ID
NCT03739684
Phase
Phase 3
Study Type
Interventional
Last Updated