Clinical trial NCT04854343: SLPI for Prostate Cancer
Official title: SLPI: a Novel Biomarker of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Prostatic Neoplasm
Keywords: Prostate
SLPI
Prostate Cancer
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Istituto per lo Studio, la Prevenzione e la Rete Oncologica
name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2021-04-22
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be enroll patient with prostate carcinoma and, as control groups, patients with benign prostate hyperplasia (BPH) and males older than 50 years with neither prostate disease nor any other neoplasia.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SLPI and Clinical data
timeFrame: through study completion, at least 15 months
measure: SLPI and Pathological data
timeFrame: Enrollment
measure: SLPI and Molecular Features
timeFrame: Enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi University Hospital
state: Tuscany
Study officials:
affiliation: ISPRO
name: Rosario Notaro, MD
role: PRINCIPAL_INVESTIGATOR
References: