TheranosticTrials.org

Clinical Trial · NCT02691169

Integrated 18F-labelled PSMA Project

Overview

There are several new therapies available to treat men with advanced prostate cancer; however, the decision making tools needed to determine the best treatment for these patients are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being recognized as an important target for prostate cancer imaging and determining the most effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One of these agents is 18F-DCFPyL. In this study the investigators will image men with advanced prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT) scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection of metastases and monitoring the effects of therapy with conventional imaging (CT, bone scan) and clinical follow-up. In this way, the investigators will evaluate the benefit of using 18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with advanced prostate cancer.

Sponsor

Unknown Organization

Phase

Early Phase 1

Contacts

Katherine Zukotynski, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02691169

Drug / Compound

DCFPyL

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

Eligibility

Inclusion

  • Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:
  • Prior docetaxel-based chemotherapy is permitted but not required
  • Rising PSA over a minimum 1-week interval
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Subjects starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone), within approximately 1-7 days of the baseline 18F-DCFPyL PET/CT.
  • Ongoing androgen deprivation

Exclusion

  • Known brain metastasis