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SLPI for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04854343
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
Istituto per lo Studio, la Prevenzione e la Rete Oncologica
Azienda Ospedaliero-Universitaria Careggi
Information provided by (Responsible Party):
Simone Morselli, University of Florence

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.

Condition or disease Intervention/treatment
Prostate Cancer Prostatic Neoplasm Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) in prostate cancer Diagnostic Test: Determination of molecular alterations Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) Healthy

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.

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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: SLPI: a Novel Biomarker of Prostate Cancer
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Case
200 patients with a suspicion of prostate cancer
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


Diagnostic Test: 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.

Control A
(a) 50 patients with benign prostate hyperplasia (BPH)
Diagnostic Test: 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.

Diagnostic Test: 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".


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

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".





Primary Outcome Measures :
  1. SLPI and Clinical data [ Time Frame: through study completion, at least 15 months ]
    Correlation between clinical data of prostate cancer and SLPI levels

  2. SLPI and Pathological data [ Time Frame: Enrollment ]
    Correlation between pathological data of prostate cancer and SLPI levels

  3. SLPI and Molecular Features [ Time Frame: Enrollment ]
    Correlation between molecular features of prostate cancer and SLPI levels



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854343


Contacts
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Contact: Silvia Benemei 055 7946999 silvia.benemei@unifi.it

Locations
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Italy
Careggi University Hospital Recruiting
Florence, Tuscany, Italy, 50134
Contact: Simone Morselli, MD    3473050852    simone.morselli@unifi.it   
Contact: Sergio Serni, Prof       sergio.serni@unifi.it   
Principal Investigator: Sergio Serni, Prof         
Sub-Investigator: Mauro Gacci, MD         
Sub-Investigator: Simone Morselli, MD         
Principal Investigator: Gabriella Nesi, Prof         
Principal Investigator: Rosario Notaro, MD         
Principal Investigator: Gianni Amunni, Prof         
Principal Investigator: Maria De Angioletti, PhD         
Sub-Investigator: Riccardo Campi, MD         
Sub-Investigator: Rossella Nicoletti, MD         
Sub-Investigator: Lorenzo Verdelli, MD         
Sub-Investigator: Alessio Taddei, MD         
Sponsors and Collaborators
University of Florence
Istituto per lo Studio, la Prevenzione e la Rete Oncologica
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Principal Investigator: Rosario Notaro, MD ISPRO
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Responsible Party: Simone Morselli, PhD Student, University of Florence
ClinicalTrials.gov Identifier: NCT04854343    
Other Study ID Numbers: 17931
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simone Morselli, University of Florence:
Prostate
SLPI
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
HIV Protease Inhibitors
Protease Inhibitors
Secretory Leukocyte Peptidase Inhibitor
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Serine Proteinase Inhibitors