Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

NCT04976257 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 21921NCI-2021-06580
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Ga68-PSMA-11

Outcome Measures

Primary Outcomes (1)

• Maximum standardized uptake value (SUVmax)

  A two-sided paired t-test will determine whether the ipsilateral SUVmax values obtained during selective arterial 68Ga-PSMA-11 infusions are greater than those obtained during venous infusions. A similar paired analysis will be made during arterial infusions to compare tumoral regions of interest (ROIs) ipsilateral and contralateral to the side of the infusion. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  Day 1 and from Day 2 up to Day 15 (2 days total)

Secondary Outcomes (7)

• Comparison of Mean SUV (SUVmean)

  Day 1 and from Day 2 up to Day 15 (2 days total)

• Comparison of Time to SUVmax (TSUV)

  Day 1 and from Day 2 up to Day 15 (2 days total)

• Comparison of Area under the curve (AUC)

  Day 1 and from Day 2 up to Day 15 (2 days total)

• Comparison of Rate of 68Ga-PSMA-11 uptake

  Day 1 and from Day 2 up to Day 15 (2 days total)

• Comparison of Time to early saturation effects

  1 day

Study Arms (1)

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization

EXPERIMENTAL

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. One to 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.

Procedure: Angiogram; Procedure: Catheterization; Drug: Gallium Ga-labeled PSMA-11; Procedure: Positron Emission Tomography

Interventions

Angiogram PROCEDURE

Undergo angiogram

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization

Catheterization PROCEDURE

Undergo prostatic arterial catheterization

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization

Gallium Ga-labeled PSMA-11 DRUG

Given IV and IA

Also known as: 68Ga-PSMA-11

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial Catheterization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years and less than or equal to 80 years.
• Children are excluded from this study because the disease does not occur in children
• Individuals from age 76 to age 80 must have a prior CT of the abdomen and pelvis within 5 years of first PSMA scan demonstrating non-occlusive pelvic atherosclerosis, regardless of smoking status
• Individuals over the age of 80 are excluded from this study to improve the likelihood of a catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age
• Ability to provide informed consent
• Biopsy-proven unilateral or bilateral prostate adenocarcinoma, any stage (any N or any M)
• Large tumor burden, characterized by either
• 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.
• 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
• Cancer of the Prostate Risk Assessment (CAPRA) score \>= 6

You may not qualify if:

• Body mass index (BMI) \> 35 kg/m\^2
• Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan
• History of any pelvic radiotherapy
• Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
• Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan
• Platelet count \< 50 x 10\^9/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

Sponsors & Collaborators

• Ryan Kohlbrenner, MD: lead
• Radiological Society of North America: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Magnuska ZA, Roy R, Palmowski M, Kohlen M, Winkler BS, Pfeil T, Boor P, Schulz V, Krauss K, Stickeler E, Kiessling F. Combining Radiomics and Autoencoders to Distinguish Benign and Malignant Breast Tumors on US Images. Radiology. 2024 Sep;312(3):e232554. doi: 10.1148/radiol.232554.

  PMID: 39254446 DERIVED

• Kohlbrenner R, Wu X, Nguyen HG, Cooperberg MR, Chakravarty T, Carroll PR, Hope TA. Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA PET/CT Radioligand Infusions in Primary Prostatic Adenocarcinoma. Radiology. 2024 Aug;312(2):e232544. doi: 10.1148/radiol.232544.

  PMID: 39136560 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Catheterization; gallium 68 PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Ryan Kohlbrenner

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 26, 2021
• Study Start: October 13, 2021
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)