TheranosticTrials.org

Clinical Trial · NCT04976257

Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

Overview

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

Sponsor

University of California, San Francisco

Phase

Early Phase 1

Contacts

Ryan Kohlbrenner (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04976257

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Large tumor burden, characterized by either
  • Infiltrative disease with primary pattern Gleason 4 adenocarcinoma in at least 4 of 6 sextant core biopsy locations on at least one affected side, documented in a surgical pathology report within 4 months of first scan.
  • Gleason score \>= 4+4
  • A discrete lesion with maximal tumor diameter \>= 2.0cm on at least one affected side, documented on prostate magnetic resonance imaging (MRI) or Transrectal ultrasound (TRUS) within 4 months of first scan.
  • Cancer of the Prostate Risk Assessment (CAPRA) score \>= 6
  • Children are excluded from this study because the disease does not occur in children
  • Biopsy-proven unilateral or bilateral prostate adenocarcinoma, any stage (any N or any M)

Exclusion

  • Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan
  • Platelet count \< 50 x 10\^9/L and/or international normalized ratio \> 1.5
  • Inability to tolerate prolonged supine positioning
  • Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
  • Body mass index (BMI) \> 35 kg/m\^2
  • History of any pelvic radiotherapy
  • Severe allergy to iodinated contrast
  • Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan
  • Active urinary tract infection or recent episode of prostatitis within 1 month of first scan