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Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

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ClinicalTrials.gov Identifier: NCT04976257
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : October 21, 2021
Sponsor:
Collaborator:
Radiological Society of North America
Information provided by (Responsible Party):
Ryan Kohlbrenner, MD, University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
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 Procedure: Angiogram Procedure: Catheterization Drug: Gallium Ga-labeled PSMA-11 Procedure: Positron Emission Tomography Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : April 29, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Angiogram
Undergo angiogram

Procedure: Catheterization
Undergo prostatic arterial catheterization

Drug: Gallium Ga-labeled PSMA-11
Given IV and IA
Other Name: 68Ga-PSMA-11

Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Maximum standardized uptake value (SUVmax) [ Time Frame: Day 1 and from Day 2 up to Day 15 (2 days total) ]
    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.


Secondary Outcome Measures :
  1. Comparison of Mean SUV (SUVmean) [ Time Frame: Day 1 and from Day 2 up to Day 15 (2 days total) ]
    Paired t-tests will determine whether SUVmean is different for intra-arterial (IA) time activity curves (TACs) when compared to intravenous (IV) TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  2. Comparison of Time to SUVmax (TSUV) [ Time Frame: Day 1 and from Day 2 up to Day 15 (2 days total) ]
    Paired t-tests will determine whether TSUV is different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  3. Comparison of Area under the curve (AUC) [ Time Frame: Day 1 and from Day 2 up to Day 15 (2 days total) ]
    Paired t-tests will determine whether AUCs are different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  4. Comparison of Rate of 68Ga-PSMA-11 uptake [ Time Frame: Day 1 and from Day 2 up to Day 15 (2 days total) ]
    To assess whether the rate of uptake is significantly different with selective arterial infusion, a two-sided paired t-test will compare the slopes for Selective arterial infusion, tumor ipsilateral to the side of radiotracer injection (IAIpsi) curves and Intravenous infusion, tumor ipsilateral to the side of corresponding arterial injection (IVIpsi) curves during each of the nine time intervals. Selective arterial infusion, tumor contralateral to the side of radiotracer injection (IACont) slopes will be similarly compared to those acquired from corresponding Intravenous infusion, tumor contralateral to the side of corresponding arterial injection (IVCont) data. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  5. Comparison of Time to early saturation effects [ Time Frame: 1 day ]
    Specific to the IAIpsi TACs, the time to early saturation effects (Tese) will represent the time at which the second derivative of the curve becomes negative (i.e. when concavity in the curve is first noted). For the purposes of Tese, the aforementioned curve partitioning method will not be used. Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  6. Comparison of Mass dose at saturation [ Time Frame: Day 1 and from Day 2 up to Day 15 (2 days total) ]
    Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

  7. Comparison of Mean SUV during 15-minute washout (SUVwashout) [ Time Frame: 1 day ]
    The mean SUVwashout and its standard deviation will be calculated for the 15-minute post-injection periods.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Body mass index (BMI) > 30 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976257


Contacts
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Contact: Maya Aslam 877-827-3222 Maya.Aslam@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Maya Aslam    877-827-3222    Maya.Aslam@ucsf.edu   
Contact       cancertrials@ucsf.edu   
Principal Investigator: Ryan Kohlbrenner, MD         
Sub-Investigator: Thomas Hope, MD         
Sub-Investigator: Peter R Carroll, MD         
Sponsors and Collaborators
Ryan Kohlbrenner, MD
Radiological Society of North America
Investigators
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Principal Investigator: Ryan Kohlbrenner University of California, San Francisco
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Responsible Party: Ryan Kohlbrenner, MD, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04976257    
Other Study ID Numbers: 21921
NCI-2021-06580 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ryan Kohlbrenner, MD, University of California, San Francisco:
Ga68-PSMA-11
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action