Prostate CancerNCT04854343
SLPI for Prostate Cancer
An observational study of Prostate Cancer and Prostatic Neoplasm, run by University of Florence at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasm
- What is being tested?
- Secretory leukocyte protease inhibitor (SLPI) in prostate cancer, Determination of molecular alterations and Secretory leukocyte protease inhibitor (SLPI) Healthy
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with prostate carcinoma.
- Patients with Benign Prostatic Hyperplasia.
- Male subjects older that 50 years without prostate or neoplastic diseases.
Who cannot join
- Male subjects younger that 50 years without prostate disease.
- Male subjects with neoplastic diseases either than prostate.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Careggi University Hospital
Florence, Tuscany, 50134
Simone Morselli, MD, 3473050852, simone.morselli@unifi.it
Sergio Serni, Prof, sergio.serni@unifi.it
About this study
Official title: SLPI: a Novel Biomarker of Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer, Prostatic Neoplasm
- Being tested
- Secretory leukocyte protease inhibitor (SLPI) in prostate cancer, Determination of molecular alterations, Secretory leukocyte protease inhibitor (SLPI) Healthy
- Keywords
- Prostate, SLPI, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secretory leukocyte protease inhibitor (SLPI) in prostate cancerDiagnostic 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
Determination of molecular alterationsDiagnostic 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.
Secretory leukocyte protease inhibitor (SLPI) HealthyDiagnostic 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".
| Study group | Role | What they receive |
|---|---|---|
| Case | 200 patients with a suspicion of prostate cancer Receives: 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) Receives: 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 Receives: Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLPI and Clinical data
Correlation between clinical data of prostate cancer and SLPI levels
Measured: through study completion, at least 15 months
SLPI and Pathological data
Correlation between pathological data of prostate cancer and SLPI levels
Measured: Enrollment
SLPI and Molecular Features
Correlation between molecular features of prostate cancer and SLPI levels
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Principal investigator, Simone Morselli, University of Florence
- Investigators
- Rosario Notaro, MD, Principal investigator, ISPRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854343
- Sponsor's protocol ID
- 17931
- Status last verified
- May 2022
- First submitted
- 13 Apr 2021
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLPI: a Novel Biomarker of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04854343
- Acronym / sponsor ID
- 17931
- Conditions
- Prostate Cancer, Prostatic Neoplasm
- Keywords
- Prostate, SLPI, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Azienda Ospedaliero-Universitaria Careggi
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) in prostate cancer, Diagnostic Test: Determination of molecular alterations200 patients with a suspicion of prostate cancer |
| Control A | – | Diagnostic Test: Determination of molecular alterations, Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) Healthy(a) 50 patients with benign prostate hyperplasia (BPH) |
| Control B | – | Diagnostic Test: Secretory leukocyte protease inhibitor (SLPI) Healthy(b) 30 male subjects older than 50 years with neither prostate disease nor any other neoplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with prostate carcinoma.
- Patients with Benign Prostatic Hyperplasia.
- Male subjects older that 50 years without prostate or neoplastic diseases.
Key exclusion criteria (2 listed)
- Male subjects younger that 50 years without prostate disease.
- Male subjects with neoplastic diseases either than prostate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secretory leukocyte protease inhibitor (SLPI) in prostate cancer7 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 | Case |
| Determination of molecular alterationsThe 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 | Case, Control A |
| Secretory leukocyte protease inhibitor (SLPI) HealthySLPI 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". | Diagnostic test | Control A, Control B |
Primary outcome
SLPI and Clinical data
Time frame: through study completion, at least 15 months
Correlation between clinical data of prostate cancer and SLPI levels
SLPI and Pathological data
Time frame: Enrollment
Correlation between pathological data of prostate cancer and SLPI levels
SLPI and Molecular Features
Time frame: Enrollment
Correlation between molecular features of prostate cancer and SLPI levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosario Notaro, MD principal investigator
ISPRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostatic Neoplasm, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Benemei (055 7946999, silvia.benemei@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLPI and Clinical data (time frame: through study completion, at least 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.