TheranosticTrials.org

Clinical Trial · NCT03800784

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

Overview

This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 2/3

Contacts

Mark Markowski (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03800784

Drug / Compound

DCFPyL

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

Eligibility

Inclusion

  • Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
  • No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
  • Cohort B: mCRPC
  • Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
  • Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.
  • PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
  • Histological confirmation of prostate cancer
  • Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
  • Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
  • Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
  • PSADT ≤ 9 months

Exclusion

  • Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging