TheranosticTrials.org

Clinical Trial · NCT03388346

68Ga PSMA in Preprostatectomy Patients

Overview

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Sponsor

University of Iowa

Phase

Phase 2/3

Contacts

Michael Graham, MD, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT03388346

Drug / Compound

PSMA-HBED-CC

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • A PSA level resulted within the past 2 months
  • Biopsy-proven prostate adenocarcinoma
  • Planned prostatectomy with lymph node dissection
  • Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)
  • Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months
  • Intermediate to high-risk disease, defined as one of the following factors: PSA \> 10, T2b or greater, or a Gleason score of 7 or greater
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations

Exclusion

Exclusion criteria not yet provided.