Prostate CancerNCT06637267
Prospective Evaluation of Proclarix® Test to Improve Risk Stratification in Men Scheduled for MpMRI and Prostate Biopsy in Cantonal Hospital Aarau
An observational study of Prostate Cancer, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The use of prostate-specific antigen (PSA) for the screening of prostate cancer has led to higher detection rates and a shift to lower and therefore potentially more curative disease stages at diagnosis and thus subsequently to a lower mortality. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Proclarix®
- How many people
- 480 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Aug 2022to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients between 45 and 80 years of age who are scheduled for an mpMRI followed by prostate biopsy (systematic and / or TRUS fusion biopsy) - within the framework of standard of care
Who may be able to join
- Male patients between 45 and 80 years of age who are scheduled for an mpMRI followed by prostate biopsy (systematic and / or TRUS fusion biopsy) - within the framework of standard of care
- Signed ICE
Who cannot join
- patients who had previous treatments of the prostate (TUR prostate, cryoablation, HIFU, IRE, radiation therapy, alcohol instillation, etc.) in the past 5 years.
- acute urinary tract infections.
- the use of 5-alpha reductase inhibitors.
- mpMRI performed outside of the scope of Kantonsspital Aarau.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital Aarau
Aarau, Canton of Aargau, 5001
Maciej Kwiatkowski, PD, 0041 62 838 4736, Maciej.Kwiatkowski@ksa.ch
Lukas Prause, Dr, 0041 62 838 4736, lukas.prause@ksa.ch
About this study
The use of prostate-specific antigen (PSA) for the screening of prostate cancer has led to higher detection rates and a shift to lower and therefore potentially more curative disease stages at diagnosis and thus subsequently to a lower mortality. A suspicious digital rectal examination of the prostate or an increased PSA value are suspicious for PCa and indicate a confirmatory prostate biopsy . Almost 25% of all men report moderate to severe pain after the biopsy. Serious complications such as urosepsis requiring intensive medical monitoring are less common. There are also other predictors for the presence of prostate cancer: including positive family history in first-degree relatives, low PSA-ratio (= ratio between free to total PSA), older age and African-American race. In order to reduce the number of unnecessary prostate biopsies, numerous prostate-cancer risk calculators based on these predictors have been designed. Risk-calculators serve as an aid to clinical decision-making. For example, if the calculated risk of prostate cancer is low, a PSA follow-up can be a viable alternative to prostate biopsy. However, these risk calculators often have some shortcomings. The two most frequently used calculators are based on cohorts of men in whom the biopsies were performed as part of a study protocol regardless of the clinical context. These cohorts do not realistically represent the collective of patients to whom a prostate biopsy is indicated. Furthermore, the cohorts of these calculators are mostly very old and do not take into account the technical developments with improved sensitivity/specificity in recent years. Nowadays, a multiparametric magnetic resonance imaging (mpMRI) of the prostate is being performed and suspicious areas in the prostate are explicitly targeted, leading to an improved detection of significant carcinoma.The possibility of determining novel laboratory predictors such as biomarkers has been lately under investigation. All of these biomarkers are not included in the currently available risk calculators or are poorly validated. A pathological grading system, the so-called Gleason score, is a pathological grading system differentiating between less versus more aggressive prostate cancer cells. The most frequently used risk calculators have been developed based on patient cohorts that were created at a time before the Gleason score was revised to its current status. Thus, many previously low-grade carcinomas would be classified as more aggressive ones according to current pathology guidelines. Based on these circumstances, the development of a new PCa risk stratification models is of major clinical importance. In addition, as all biomarker measurements rely heavily on analytical performance of laboratory equipment, the quality assurance is an important factor and should be under scrutiny, especially when new biomarkers are under investigation.
Proclarix is a CE-marked test based on two new biomarkers, Thrombospondin 1 (THBS1) and Cathepsin D (CTSD), combined with PSA values and the patient's age. A software algorithm returns a risk assessment that can be utilized to predict clinically significant PCa (ISUP group 2 or higher).
Read the detailed description
Hypothesis and primary objective The aim of the study is the implementation of new biomarkers (Proclarix) in order to increase the sensitivity and specificity of PSA-based PCa early detection avoiding unnecessary prostate biopsies thus decreasing the associated morbidity (infections, bleeding, urinary retention, etc.). PSA values, Proclarix and mpMRI findings will be correlated with the results of the prostate biopsy in order to improve patient selection for future biopsies in order to avoid unnecessary prostate biopsies, but still be able to detect relevant carcinomas at an early stage. The null hypothesis in our observational study is the lack of superiority in PCa early detection when using the Proclarix over PSA alone.
Primary and secondary endpoints The primary endpoint is the sensitivity and specificity of the Proclarix risk score in relation to the prediction of significant prostate cancer (Gleason score >7) in the prostate biopsy. These parameters should be compared to PSA, %fPSA and the mpMRI findings.
The secondary endpoints:
The correlation of the data collected from mpMRI (according to PI-RADS) to the biopsy results. The combination of clinical parameters, PSA values, Proclarix, mpMRI and pathology results in order to develop predictive risk stratification tool (e.g. risk score or nomogram) for PCa.
Determination of the analytical performance of the recently introduced Alinity i-Systems for PSA determination compared to the Architect i2000sr system (Abbott Laboratories) in terms of precision and validation of the reference interval according to the CLSI guidelines.
The study design of this single-center, single-arm, non-blinded prospective study includes the collection and storage of 40 ml serum from all patients who meet the inclusion criteria according to point 3.1 and are planned for a prostate biopsy as part of the routine clinical PCa workup with mpMRI of the prostate starting from September 2021. While participants are going to be recruited in prospective manner and asked for their consent, the Proclarix biomarkers as well as %fPSA and tPSA will be determined post-interventionally (analog to the PROPOSE trial).
According to the power analysis, 480 samples are necessary to achieve a 25%, statistically significant improvement in the negative predictive value of Proclarix compared to MPSA, assuming that 50% or more of all patients have a positive biopsy.
The mpMRI findings and biopsy results should be analyzed by frequency distribution and compared by standard statistical testing.The design of a risk stratification tool should be achieved by means of logistic regression analysis. Various parameter combinations should be compared by standard statistical testing.In order to evaluate the performance of the recently introduced Alinity i system for PSA assays in terms of precision and correlation compared to the Architect i2000sr system (Abbott Laboratories) and to validate the reference interval according to CLSI guidelines, approximately 100 serum samples will be included for the comparison of the two methods by means of standard statistical testing. SPSS v.24 standard statistical package will be used for the most of the data analysis. The statistical analysis will be performed with assistance of external statistician. P-value <0.05 or diverging boundaries of 95% confidence intervals will be considered as statistically significant.
- Conditions
- Prostate Cancer
- Being tested
- Proclarix®
- Keywords
- Proclarix
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proclarix®Diagnostic test
Also called Proclarix risk score
The aim of the study is the implementation of new biomarkers (Proclarix®) in order to increase the sensitivity and specificity of PSA-based Prostate cancer early detection avoiding unnecessary prostate biopsies thus decreasing the associated morbidity (infections, bleeding, urinary retention, etc.). PSA values, Proclarix and mpMRI findings will be correlated with the results of the prostate biopsy in order to improve patient selection for future biopsies in order to avoid unnecessary prostate biopsies, but still be able to detect relevant carcinomas at an early stage. The null hypothesis in our observational study is the lack of superiority in PCa early detection when using the Proclarix over PSA alone.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the Proclarix risk score detenging clinically relevant prostate cancer.
The primary endpoint is the sensitivity and specificity of the Proclarix risk score in relation to the prediction of significant prostate cancer (Gleason score >7) in the prostate biopsy. These parameters should be compared to PSA, %fPSA and the mpMRI findings.
Measured: August 2022 - July 2024
Secondary outcomes (3)
The correlation of the data collected from mpMRI (according to PI-RADS) to the biopsy results.
The correlation of the data collected from mpMRI (according to PI-RADS) to the biopsy results.
Measured: August 2022 - July 2024
The combination of clinical parameters, PSA values, Proclarix, mpMRI and pathology results in order to develop predictive risk stratification tool (e.g. risk score or nomogram) for PCa.
The combination of clinical parameters, PSA values, Proclarix, mpMRI and pathology results in order to develop predictive risk stratification tool (e.g. risk score or nomogram) for PCa.
Measured: August 2022 - July 2024
Development of a Predictive Risk Stratification Tool for Clinically Significant Prostate Cancer
This outcome measure focuses on the development of a predictive risk stratification tool for identifying clinically significant prostate cancer (Gleason score ≥7). The tool will combine multiple clinical and diagnostic parameters, including:
- Prostate-Specific Antigen (PSA) levels measured in ng/mL.
- Multiparametric MRI (mpMRI) findings, assessed using the PI-RADS score (Prostate Imaging Reporting and Data System).
- Proclarix risk score, a biomarker-based tool for prostate cancer risk assessment.
- Pathology results from prostate biopsy, specifically Gleason scores.
Measured: August 2022 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start24 Aug 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Maciej Kwiatkowski, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637267
- Sponsor's protocol ID
- 00175
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. The investigator plan to make our results available to researchers and potential collaborators interested in prostate cancer screening
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Proclarix® Test to Improve Risk Stratification in Men Scheduled for MpMRI and Prostate Biopsy in Cantonal Hospital Aarau
- ClinicalTrials.gov ID
- NCT06637267
- Acronym / sponsor ID
- 00175
- Conditions
- Prostate Cancer
- Keywords
- Proclarix
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (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 use of prostate-specific antigen (PSA) for the screening of prostate cancer has led to higher detection rates and a shift to lower and therefore potentially more curative disease stages at diagnosis and thus subsequently to a lower mortality. A suspicious digital rectal examination of the prostate or an increased PSA value are suspicious for PCa and indicate a confirmatory prostate biopsy . Almost 25% of all men report moderate to severe pain after the biopsy. Serious complications such as urosepsis requiring intensive medical monitoring are less common. There are also other predictors for the presence of prostate cancer: including positive family history in first-degree relatives, low PSA-ratio (= ratio between free to total PSA), older age and African-American race. In order to reduce the number of unnecessary prostate biopsies, numerous prostate-cancer risk calculators based on these predictors have been designed. Risk-calculators serve as an aid to clinical decision-making. For example, if the calculated risk of prostate cancer is low, a PSA follow-up can be a viable alternative to prostate biopsy. However, these risk calculators often have some shortcomings. The two most frequently used calculators are based on cohorts of men in whom the biopsies were performed as part of a study protocol regardless of the clinical context. These cohorts do not realistically represent the collective of patients to whom a prostate biopsy is indicated. Furthermore, the cohorts of these calculators are mostly very old and do not take into account the technical developments with improved sensitivity/specificity in recent years. Nowadays, a multiparametric magnetic resonance imaging (mpMRI) of the prostate is being performed and suspicious areas in the prostate are explicitly targeted, leading to an improved detection of significant carcinoma.The possibility of determining novel laboratory predictors such as biomarkers has been lately under investigation. All of these biomarkers are not included in the currently available risk calculators or are poorly validated. A pathological grading system, the so-called Gleason score, is a pathological grading system differentiating between less versus more aggressive prostate cancer cells. The most frequently used risk calculators have been developed based on patient cohorts that were created at a time before the Gleason score was revised to its current status. Thus, many previously low-grade carcinomas would be classified as more aggressive ones according to current pathology guidelines. Based on these circumstances, the development of a new PCa risk stratification models is of major clinical importance. In addition, as all biomarker measurements rely heavily on analytical performance of laboratory equipment, the quality assurance is an important factor and should be under scrutiny, especially when new biomarkers are under investigation.
Proclarix is a CE-marked test based on two new biomarkers, Thrombospondin 1 (THBS1) and Cathepsin D (CTSD), combined with PSA values and the patient's age. A software algorithm returns a risk assessment that can be utilized to predict clinically significant PCa (ISUP group 2 or higher).
Detailed description
Hypothesis and primary objective The aim of the study is the implementation of new biomarkers (Proclarix) in order to increase the sensitivity and specificity of PSA-based PCa early detection avoiding unnecessary prostate biopsies thus decreasing the associated morbidity (infections, bleeding, urinary retention, etc.). PSA values, Proclarix and mpMRI findings will be correlated with the results of the prostate biopsy in order to improve patient selection for future biopsies in order to avoid unnecessary prostate biopsies, but still be able to detect relevant carcinomas at an early stage. The null hypothesis in our observational study is the lack of superiority in PCa early detection when using the Proclarix over PSA alone.
Primary and secondary endpoints The primary endpoint is the sensitivity and specificity of the Proclarix risk score in relation to the prediction of significant prostate cancer (Gleason score >7) in the prostate biopsy. These parameters should be compared to PSA, %fPSA and the mpMRI findings.
The secondary endpoints:
The correlation of the data collected from mpMRI (according to PI-RADS) to the biopsy results. The combination of clinical parameters, PSA values, Proclarix, mpMRI and pathology results in order to develop predictive risk stratification tool (e.g. risk score or nomogram) for PCa.
Determination of the analytical performance of the recently introduced Alinity i-Systems for PSA determination compared to the Architect i2000sr system (Abbott Laboratories) in terms of precision and validation of the reference interval according to the CLSI guidelines.
The study design of this single-center, single-arm, non-blinded prospective study includes the collection and storage of 40 ml serum from all patients who meet the inclusion criteria according to point 3.1 and are planned for a prostate biopsy as part of the routine clinical PCa workup with mpMRI of the prostate starting from September 2021. While participants are going to be recruited in prospective manner and asked for their consent, the Proclarix biomarkers as well as %fPSA and tPSA will be determined post-interventionally (analog to the PROPOSE trial).
According to the power analysis, 480 samples are necessary to achieve a 25%, statistically significant improvement in the negative predictive value of Proclarix compared to MPSA, assuming that 50% or more of all patients have a positive biopsy.
The mpMRI findings and biopsy results should be analyzed by frequency distribution and compared by standard statistical testing.The design of a risk stratification tool should be achieved by means of logistic regression analysis. Various parameter combinations should be compared by standard statistical testing.In order to evaluate the performance of the recently introduced Alinity i system for PSA assays in terms of precision and correlation compared to the Architect i2000sr system (Abbott Laboratories) and to validate the reference interval according to CLSI guidelines, approximately 100 serum samples will be included for the comparison of the two methods by means of standard statistical testing. SPSS v.24 standard statistical package will be used for the most of the data analysis. The statistical analysis will be performed with assistance of external statistician. P-value <0.05 or diverging boundaries of 95% confidence intervals will be considered as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients between 45 and 80 years of age who are scheduled for an mpMRI followed by prostate biopsy (systematic and / or TRUS fusion biopsy) - within the framework of standard of care
Key inclusion criteria (2 listed)
- Male patients between 45 and 80 years of age who are scheduled for an mpMRI followed by prostate biopsy (systematic and / or TRUS fusion biopsy) - within the framework of standard of care
- Signed ICE
Key exclusion criteria (4 listed)
- patients who had previous treatments of the prostate (TUR prostate, cryoablation, HIFU, IRE, radiation therapy, alcohol instillation, etc.) in the past 5 years.
- acute urinary tract infections.
- the use of 5-alpha reductase inhibitors.
- mpMRI performed outside of the scope of Kantonsspital Aarau.
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 |
|---|---|---|
| Proclarix®Also: Proclarix risk scoreThe aim of the study is the implementation of new biomarkers (Proclarix®) in order to increase the sensitivity and specificity of PSA-based Prostate cancer early detection avoiding unnecessary prostate biopsies thus decreasing the associated morbidity (infections, bleeding, urinary retention, etc.). PSA values, Proclarix and mpMRI findings will be correlated with the results of the prostate biopsy in order to improve patient selection for future biopsies in order to avoid unnecessary prostate biopsies, but still be able to detect relevant carcinomas at an early stage. The null hypothesis in our observational study is the lack of superiority in PCa early detection when using the Proclarix over PSA alone. | Diagnostic test | – |
Primary outcome
Sensitivity and specificity of the Proclarix risk score detenging clinically relevant prostate cancer.
Time frame: August 2022 - July 2024
The primary endpoint is the sensitivity and specificity of the Proclarix risk score in relation to the prediction of significant prostate cancer (Gleason score >7) in the prostate biopsy. These parameters should be compared to PSA, %fPSA and the mpMRI findings.
3 secondary outcomes
The correlation of the data collected from mpMRI (according to PI-RADS) to the biopsy results.
Time frame: August 2022 - July 2024
The combination of clinical parameters, PSA values, Proclarix, mpMRI and pathology results in order to develop predictive risk stratification tool (e.g. risk score or nomogram) for PCa.
Time frame: August 2022 - July 2024
Development of a Predictive Risk Stratification Tool for Clinically Significant Prostate Cancer
Time frame: August 2022 to December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. The investigator plan to make our results available to researchers and potential collaborators interested in prostate cancer screening
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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.
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 Kantonsspital Aarau at 1 site in Switzerland.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the Proclarix risk score detenging clinically relevant prostate cancer. (time frame: August 2022 - July 2024). 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 15 Oct 2024.