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

Jonsson Comprehensive Cancer Center

Status and phase: Active, not recruiting; Phase 1

Conditions: Metastatic Malignant Neoplasm in the Prostate Gland; Prostate Carcinoma; Recurrent Prostate Carcinoma

Treatments: Procedure: Positron Emission Tomography; Other: Gallium Ga 68 FAPi-46; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT04457232

NCI-2020-02712 (Registry Identifier)

20-000177 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Basic Science (68Ga-FAPi-46 PET/CT)

Experimental group

Description:

Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.

Treatment:

Procedure: Computed Tomography

Other: Gallium Ga 68 FAPi-46

Procedure: Positron Emission Tomography