TheranosticTrials.org

Clinical Trial · NCT04179968

The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

Overview

To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).

Sponsor

University of Texas Southwestern Medical Center

Phase

Phase 2

Contacts

Orhan K Oz, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04179968

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Patients must be scheduled for biopsy or radical prostatectomy
  • Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
  • Patients must be medically stable as judged by the patient's physician
  • Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
  • Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
  • Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
  • In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.

Exclusion

  • Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
  • Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies
  • Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (\>200 kilograms or 440 pounds)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
  • Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
  • Patients who have had a prior biopsy for prostate cancer cannot participate in the study
  • Patients who have been treated for cancers other than skin cancers