Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT imaging
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT imaging
Sponsors
Prostate Cancer Foundation
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging | 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. |
Countries
United States
Outcome results
None listed