Summary

Eligibility
for males ages 18-70 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Ryan Kohlbrenner
Photo of Ryan Kohlbrenner
Ryan Kohlbrenner

Description

Summary

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).

Official Title

Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients

Details

PRIMARY OBJECTIVE: I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions. SECONDARY OBJECTIVES: I. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions. II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves [TACs] ipsilateral to the side of infusion). OUTLINE: Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after. After completion of study, patients are followed up with 24 hours after the IA infusion and PET scan.

Keywords

Prostate Adenocarcinoma Prostate Carcinoma Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Ga68-PSMA-11 Prostatic Neoplasms Angiogram Catheterization Gallium Ga-labeled PSMA-11 Positron Emission Tomography Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization

Eligibility

You can join if…

Open to males ages 18-70

  • Age greater than or equal to 18 years and less than or equal to 70 years
  • Children are excluded from this study because the disease does not occur in children
  • Individuals over the age of 70 are excluded from this study to improve the likelihood of at least one catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age
  • Ability to provide informed consent
  • Biopsy-proven bilateral prostate adenocarcinoma (within 3 months of first scan), any stage (using the TNM Staging criteria, any N or any M)
  • Maximal tumor diameter >= 2.0 cm on each side, documented on prostate magnetic resonance imaging (MRI) within 3 months of first scan
  • Gleason score >= 4+4
  • Cancer of the Prostate Risk Assessment (CAPRA) score >= 6

You CAN'T join if...

  • Body mass index (BMI) > 30 kg/m2

  • Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan
  • History of any pelvic radiotherapy
  • Greater than 10 pack-year smoking history or severe atherosclerosis from prior CT imaging study, if available
  • Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan
  • Platelet count < 50 x 109/L and/or international normalized ratio > 1.5
  • Severe allergy to iodinated contrast
  • Active urinary tract infection or recent episode of prostatitis within 1 month of first scan
  • Inability to tolerate prolonged supine positioning

Location

  • University of California San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Ryan Kohlbrenner
    Ryan Kohlbrenner, MD, is an Assistant Professor in the Interventional Radiology subspecialty in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. He received his medical degree from the University of Chicago Pritzker School of Medicine, Illinois, and he completed a one-year internship at Washington University, St.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ryan Kohlbrenner, MD
ID
NCT04976257
Phase
Phase 1
Study Type
Interventional
Last Updated