This study is in progress, not accepting new patients

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

a study on Prostate Cancer

Summary

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

Description

Summary

This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B). Cohort B is complete and no longer recruiting subjects.

Official Title

A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)

Keywords

Prostate Cancer Diagnostic Imaging 2301 PET/CT PyL PSMA radical prostatectomy metastatic prostate cancer recurrent prostate cancer Prostatic Neoplasms 18F-DCFPyL Injection

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Histologically confirmed adenocarcinoma of the prostate.
  2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.

Cohort A Only:

  • At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8).
  • Scheduled or planned radical prostatectomy with PLND.

Cohort B Only: [Enrollment is complete; No longer recruiting subjects]

  • Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan(99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.
  • If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed.
  • Scheduled or planned percutaneous biopsy of at least one amenable lesion.

You CAN'T join if...

  1. Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days,prior to study drug injection.
  2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Cohort A Only:

  • Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention

Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]

  • Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed
  • Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.

Locations

  • University of California at San Francisco (UCSF) - Mt. Zion Hospital
    San Francisco California 94143 United States
  • Washington University Mallinckrodt Institute of Radilogy
    Saint Louis Missouri 63110 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Progenics Pharmaceuticals, Inc.
ID
NCT02981368
Phase
Phase 2/3
Study Type
Interventional
Last Updated