Prospective Evaluation of Proclarix® Test to Improve Risk Stratification in Men Scheduled for MpMRI and Prostate Biopsy in Cantonal Hospital Aarau

NCT06637267 | Recruiting DMC

• 1 other identifier: 00175
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Prostate Cancer

Keywords

Proclarix

Outcome Measures

Primary Outcomes (1)

• 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.

  August 2022 - July 2024

Secondary Outcomes (3)

• The correlation of the data collected from mpMRI (according to PI-RADS) to the biopsy results.

  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.

  August 2022 - July 2024

• Development of a Predictive Risk Stratification Tool for Clinically Significant Prostate Cancer

  August 2022 to December 2025

Interventions

Proclarix® DIAGNOSTIC_TEST

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.

Also known as: Proclarix risk score

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: Only male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kantonsspital Aarau: lead

Study Sites (1)

Cantonal Hospital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection and storage of 40 ml serum to measure the Proclarix biomarkers ( Thrombospondin 1 (THBS1) and Cathepsin D (CTSD)as well as %fPSA and tPSA).

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Maciej Kwiatkowski, Senior Consultant with a Special Function, Head of Clinical Research Urology

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 15, 2024
• Study Start: August 24, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)