SLPI for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

SLPI: a Novel Biomarker of Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854343
• Other study ID #: 17931
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2022
• Source: University of Florence
• Contact: Silvia Benemei
• Phone: 055 7946999
• Email: silvia.benemei[@]unifi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Exploratory study of SLPI expression in human prostate cancer patients This is a no-profit exploratory study about the expression of SLPI in human prostate cancer patients that will enroll about 200 patients admitted for suspect prostate cancer to Careggi University Hospital. We will verify whether an increase SLPI levels in the sera may serve as biomarker of cancer progression.

Description:

Prostate cancer (PC) is a heterogeneous disease that occurs more frequently in elderly men. Prostate cancer is usually localized and it has a slow progression; thus, the patient may not suffer from any symptom for years. However, a proportion of patients PC develops metastases and may become a clinically relevant disease that can show an aggressive behavior and, eventually, give metastases. In any event, since it is the most common male cancer in the Western countries, it is the second leading cause of cancer deaths in males. For this reason the identification of the molecular alterations determining the different clinical behaviors and of the associated biomarkers would be extremely useful.

The Secretory leukocyte protease inhibitor (SLPI) is a serine protease which best-defined function is to protect host tissues from the excessive damage by proteolytic enzymes released during inflammation. Recently SLPI has been found overexpressed in a variety of cancers (pancreatic, papillary thyroid, uterine cervix, endometrial, and ovarian cancer). In apparent contrast, SLPI has been found reduced in the sera (and tumor tissue) of prostate cancer patients in the respect of healthy subjects and of subjects with benign hyperplasia. However, SLPI has been found upregulated in castration resistant prostate cancer (CRPC) patients and in a subset of CRPC cell lines.

These data suggest that expression of SLPI in prostate cancer could be biphasic:

underexpressed during the early stages and overexpressed during progression. This peculiar pattern of SLPI expression suggests that SLPI may play a role in prostate cancer pathogenesis and/or in determining its neoplastic features. In this respect, it is noteworthy that SLPI is located at 20q13.2 (HPC20 locus), a locus harboring prostate cancer susceptibility genes. Based on these data it is possible to hypothesize that prostate cancer progression could be associated, and possibly heralded, by the increase of SLPI.

This is an observational investigation of SLPI levels in blood and tissue samples of patients with prostate disease with the explorative goal to verify whether SLPI could be a potential biomarker of prostate cancer progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 1, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with prostate carcinoma.

• Patients with Benign Prostatic Hyperplasia.

• Male subjects older that 50 years without prostate or neoplastic diseases.

Exclusion Criteria:

• Male subjects younger that 50 years without prostate disease.

• Male subjects with neoplastic diseases either than prostate.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Secretory leukocyte protease inhibitor (SLPI) in prostate cancer
7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit". SLPI level will be measured at diagnosis and during the follow-up (3, 9, 15 months and in case of progression). Immunohistochemistry protocol for SLPI immunostaining to investigate SLPI levels prostate tissue
• Determination of molecular alterations
The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.
• Secretory leukocyte protease inhibitor (SLPI) Healthy
SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects). 7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the "Human SLPI Quantikine ELISA Kit".

Locations

Country	Name	City	State
Italy	Careggi University Hospital	Florence	Tuscany

Sponsors (3)

Lead Sponsor	Collaborator
University of Florence	Azienda Ospedaliero-Universitaria Careggi, Istituto per lo Studio, la Prevenzione e la Rete Oncologica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SLPI and Clinical data	Correlation between clinical data of prostate cancer and SLPI levels	through study completion, at least 15 months
Primary	SLPI and Pathological data	Correlation between pathological data of prostate cancer and SLPI levels	Enrollment
Primary	SLPI and Molecular Features	Correlation between molecular features of prostate cancer and SLPI levels	Enrollment