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Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation (FAPI PET Prost)

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ClinicalTrials.gov Identifier: NCT04457232
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 9, 2021
Sponsor:
Collaborator:
Prostate Cancer Foundation
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Prostate Gland Prostate Carcinoma Recurrent Prostate Carcinoma Procedure: Computed Tomography Other: Gallium Ga 68 FAPi-46 Procedure: Positron Emission Tomography Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.

SECONDARY OBJECTIVES:

I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : September 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Basic Science (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
Procedure: Computed Tomography
Undergo PET/CT imaging
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Other: Gallium Ga 68 FAPi-46
Given IV
Other Names:
  • 68Ga-FAPi-46
  • Gallium-68-FAPi-46

Procedure: Positron Emission Tomography
Undergo PET/CT imaging
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. To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer [ Time Frame: 60 minutes after tracer injection ]
    To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values [SUV], SUVmean and SUVmax.


Secondary Outcome Measures :
  1. To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue [ Time Frame: Up to date of surgery (range 1-60 days) ]
    68Ga-FAPi-46 tumor SUVs will be correlated with FAP expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.

  2. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging [ Time Frame: 60 minutes after tracer injection ]
    The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax) and tested for correlation.



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

Inclusion Criteria:

  • Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment
  • Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
  • Patients can provide written informed consent
  • Patients are able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria:

  • Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT

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): NCT04457232


Contacts
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Contact: Stephanie Lira 310-206-0596 StephanieLira@mednet.ucla.edu
Contact: Kiara Booker 310-206-0596 KMBooker@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Stepanie Lira    310-206-0596    StephanieLira@mednet.ucla.edu   
Contact: Kiara Booker    310-206-0596    KMBooker@mednet.ucla.edu   
Principal Investigator: Jeremie Calais         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Prostate Cancer Foundation
Investigators
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Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04457232    
Other Study ID Numbers: 20-000177
NCI-2020-02712 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-000177 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021

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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
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
FAPI-46
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action