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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02712 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20-000177 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic Science (68Ga-FAPi-46 PET/CT) | Experimental | Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer | 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. | 60 minutes after tracer injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremie Calais | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Gallium Ga 68 FAPi-46 | Other | Given IV |
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| Positron Emission Tomography | Procedure | Undergo PET/CT imaging |
|
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| Up to date of surgery (range 1-60 days) |
| To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging | 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. | 60 minutes after tracer injection |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000706531 | FAPI-46 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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