Prostate CancerNCT03413007
Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial
An observational study of Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Immune compleX Predictive Index
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 9 Feb 2018to Dec 2018
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with prostate cancer scheduled for radical prostatectomy
Who may be able to join
- histologically proven prostate cancer,
- patients scheduled for radical prostatectomy
- paziente able to provide consent
- age > 18 years or < 80 years
Who cannot join
- neiadjuvant hormone therapy
- salvage radical prostatectomy
- concomitant solid or hematological tumors,
- autoimmune disorders
- or immunosuppressive therapies,
- acute bacterial or viral infections.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST Spedali Civili of Brescia
Brescia, BS, 25123
Simone Francavilla, +390303995215, simone.francavilla89@gmail.com
About this study
Official title: Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.
Read the detailed description
Since the 90s, serum PSA has become the cornerstone of diagnosis of PCa, However, due to its proven poor specificity, the actual role of PSA testing has been largely debated, especially if used during opportunistic screening programs. leading to a significant risk of over-diagnosis and over treatment.
In order to overcome drawbacks of PSA-based diagnostic pathway several PSA-derivates has been proposed. However, they were marginally used in clinical practice because not supplied by public health care systems.
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.
All pathological specimens are analyzed by an expert uropathologist, following ISUP reccomandations.
Before radical prostectomy a blood sample from each patients is collected. Serum PSA-IgM concentration is measured using Prostate-IC kit in duplicate. The analysis with Prostate-IC kit was performed on automated ELISA analyzer.Then the iXip index is calculated by using the online calculator (http://ixip.xeptagen.com/).
- Conditions
- Prostate Cancer
- Being tested
- Immune compleX Predictive Index
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune compleX Predictive IndexDiagnostic test
iXip is an algorithm thant integrates PSA, PSA-IgM, prostate volume and age of the patient in order to provide the probability of prostate cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between iXip and significant prostate carcer
correlation between iXip and significant prostate carcer at final pathology specimens, defined as tumor volume > 0.5 cm3 and Gleason scor equal or superior to 7. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features.
Measured: 6 months after surgery
Secondary outcomes (5)
correlation between iXip and tumor volume > 0.5 cm3
clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( >0.5cm3 tumor volume )
Measured: 6 months after surgery
correlation between iXip and tumor volume > 2.5 cm3
clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( >2.5cm3 tumor volume ).
Measured: 6 months after surgery
correlation between iXip and Gleason Score >6
clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( Gleason Score> 6)
Measured: 6 months after surgery
correlation between iXip and pathological stage > pT2
clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( pathological staging >pT2)
Measured: 6 months after surgery
correlation between iXip and positive lymph node at final pathology specimens
clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( positive lymph nodes >0)
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start9 Feb 2018
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Alessandro Antonelli, Principal investigator, Spedali Civili Hospital, Brescia (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413007
- Sponsor's protocol ID
- PSA-IgM
- Status last verified
- Jul 2018
- First submitted
- 16 Jan 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
- ClinicalTrials.gov ID
- NCT03413007
- Acronym / sponsor ID
- PSA-IgM
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jan 2018 (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.
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.
Detailed description
Since the 90s, serum PSA has become the cornerstone of diagnosis of PCa, However, due to its proven poor specificity, the actual role of PSA testing has been largely debated, especially if used during opportunistic screening programs. leading to a significant risk of over-diagnosis and over treatment.
In order to overcome drawbacks of PSA-based diagnostic pathway several PSA-derivates has been proposed. However, they were marginally used in clinical practice because not supplied by public health care systems.
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.
All pathological specimens are analyzed by an expert uropathologist, following ISUP reccomandations.
Before radical prostectomy a blood sample from each patients is collected. Serum PSA-IgM concentration is measured using Prostate-IC kit in duplicate. The analysis with Prostate-IC kit was performed on automated ELISA analyzer.Then the iXip index is calculated by using the online calculator (http://ixip.xeptagen.com/).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with prostate cancer scheduled for radical prostatectomy
Key inclusion criteria (4 listed)
- histologically proven prostate cancer,
- patients scheduled for radical prostatectomy
- paziente able to provide consent
- age > 18 years or < 80 years
Key exclusion criteria (6 listed)
- neiadjuvant hormone therapy
- salvage radical prostatectomy
- concomitant solid or hematological tumors,
- autoimmune disorders
- or immunosuppressive therapies,
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 |
|---|---|---|
| Immune compleX Predictive IndexiXip is an algorithm thant integrates PSA, PSA-IgM, prostate volume and age of the patient in order to provide the probability of prostate cancer | Diagnostic test | – |
Primary outcome
correlation between iXip and significant prostate carcer
Time frame: 6 months after surgery
correlation between iXip and significant prostate carcer at final pathology specimens, defined as tumor volume > 0.5 cm3 and Gleason scor equal or superior to 7. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features.
5 secondary outcomes
correlation between iXip and tumor volume > 0.5 cm3
Time frame: 6 months after surgery
correlation between iXip and tumor volume > 2.5 cm3
Time frame: 6 months after surgery
correlation between iXip and Gleason Score >6
Time frame: 6 months after surgery
correlation between iXip and pathological stage > pT2
Time frame: 6 months after surgery
correlation between iXip and positive lymph node at final pathology specimens
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Alessandro Antonelli principal investigator
Spedali Civili Hospital, Brescia (Italy)
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, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 4 inclusion and 6 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 19 Jul 2018. 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 Alessandro Antonelli (+390303995215, alessandro_antonelli@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between iXip and significant prostate carcer (time frame: 6 months after surgery). 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 19 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.