Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

NCT ID: NCT04976257

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2023-03-22

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).

Detailed Description

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Angiogram

Intervention Type: PROCEDURE

Undergo angiogram

Catheterization

Intervention Type: PROCEDURE

Undergo prostatic arterial catheterization

Gallium Ga-labeled PSMA-11

Intervention Type: DRUG

Given IV and IA

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET scan

Interventions

Angiogram

Undergo angiogram

Intervention Type: PROCEDURE

Catheterization

Undergo prostatic arterial catheterization

Intervention Type: PROCEDURE

Gallium Ga-labeled PSMA-11

Given IV and IA

Intervention Type: DRUG

Positron Emission Tomography

Undergo PET scan

Intervention Type: PROCEDURE

Other Intervention Names

68Ga-PSMA-11; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Radiological Society of North America

OTHER

Sponsor Role: collaborator

Ryan Kohlbrenner, MD

OTHER

Sponsor Role: lead

Responsible Party

Ryan Kohlbrenner, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ryan Kohlbrenner

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39254446 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39136560 (View on PubMed)

Other Identifiers

NCI-2021-06580

Identifier Type: REGISTRY

Identifier Source: secondary_id

21921

Identifier Type: -

Identifier Source: org_study_id