SLPI for Prostate Cancer

NCT04854343 | Unknown

• 1 other identifier: 17931
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostatic Neoplasm

Keywords

Prostate; SLPI; Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• SLPI and Clinical data

  Correlation between clinical data of prostate cancer and SLPI levels

  through study completion, at least 15 months

• SLPI and Pathological data

  Correlation between pathological data of prostate cancer and SLPI levels

  Enrollment

• SLPI and Molecular Features

  Correlation between molecular features of prostate cancer and SLPI levels

  Enrollment

Study Arms (3)

Case

200 patients with a suspicion of prostate cancer

Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) in prostate cancer; Diagnostic Test: Determination of molecular alterations

Control A

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

Diagnostic Test: Determination of molecular alterations; Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) Healthy

Control B

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

Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) Healthy

Interventions

Secretory leukocyte protease inhibitor (SLPI) in prostate cancer DIAGNOSTIC_TEST

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

Case

Determination of molecular alterations DIAGNOSTIC_TEST

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.

Case; Control A

Secretory leukocyte protease inhibitor (SLPI) Healthy DIAGNOSTIC_TEST

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".

Control A; Control B

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with prostate carcinoma.
• Patients with Benign Prostatic Hyperplasia.
• Male subjects older that 50 years without prostate or neoplastic diseases.

You may not qualify if:

• Male subjects younger that 50 years without prostate disease.
• Male subjects with neoplastic diseases either than prostate.

Sponsors & Collaborators

• University of Florence: lead
• Istituto per lo Studio, la Prevenzione e la Rete Oncologica: collaborator
• Azienda Ospedaliero-Universitaria Careggi: collaborator

Study Sites (1)

Careggi University Hospital

Florence, Tuscany, 50134, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rosario Notaro, MD

  ISPRO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Benemei

CONTACT

055 7946999; silvia.benemei@unifi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 22, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

IT (1)