Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Infective Agents

All Drugs and Chemicals

Amino Acids

HIV Protease Inhibitors

Protease Inhibitors

Secretory Leukocyte Peptidase Inhibitor

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Serine Proteinase Inhibitors

Serine

200 patients with a suspicion of prostate cancer

(a) 50 patients with benign prostate hyperplasia (BPH)

(b) 30 male subjects older than 50 years with neither prostate disease nor any other neoplasia

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

Secretory leukocyte protease inhibitor (SLPI) in prostate cancer

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.

Determination of molecular alterations

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".

Secretory leukocyte protease inhibitor (SLPI) Healthy

Silvia Benemei

Simone Morselli, MD

Sergio Serni, Prof

Mauro Gacci, MD

Gabriella Nesi, Prof

Rosario Notaro, MD

Gianni Amunni, Prof

Maria De Angioletti, PhD

Riccardo Campi, MD

Rossella Nicoletti, MD

Lorenzo Verdelli, MD

Alessio Taddei, MD

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SLPI for Prostate Cancer	NCT04854343	Prostate Cancer Prostatic Neopl...	Secretory leuko... Determination o... Secretory leuko...	18 Years -	University of Florence
SLPI for Prostate Cancer	NCT04854343	Prostate Cancer Prostatic Neopl...	Secretory leuko... Determination o... Secretory leuko...	18 Years -	University of Florence
SLPI for Prostate Cancer	NCT04854343	Prostate Cancer Prostatic Neopl...	Secretory leuko... Determination o... Secretory leuko...	18 Years -	University of Florence

Spots Global Cancer Trial Database for determination of molecular alterations