Clinical trial NCT04457232: Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
Official title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic Malignant Neoplasm in the Prostate Gland
Prostate Carcinoma
Recurrent Prostate Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2020-07-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
timeFrame: 60 minutes after tracer injection
Secondary outcomes:
measure: 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
timeFrame: Up to date of surgery (range 1-60 days)
measure: To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
timeFrame: 60 minutes after tracer injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jeremie Calais
role: PRINCIPAL_INVESTIGATOR
References: