TheranosticTrials.org

Clinical Trial · NCT03459820

Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

Overview

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

Sponsor

Unknown Organization

Phase

Phase 2/3

ClinicalTrials.gov

NCT03459820

Drug / Compound

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Clinical suspicion of advance stage disease (e.g. bone pain)Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.
  • T stage of T3 or greater on TNM staging
  • ECOG performance status 0 - 3, inclusive
  • Serum PSA \> 15 ng/ml
  • Male sex
  • Equivocal/inconclusive conventional staging such as CT, MRI or bone scan
  • Previously diagnosed with prostate cancer, under referring physician's care
  • Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injectionCohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:
  • Gleason score \> 7

Exclusion

Exclusion criteria not yet provided.