Checks the Proclarix blood test to help decide on prostate biopsy in men

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men aged 45 to 80 who are scheduled for an MRI of the prostate followed by a prostate biopsy as part of standard care.

Age

45 to 80 years

Sex

Men only

Earlier treatment

Cannot have had prostate treatments (such as TUR prostate, cryoablation, HIFU, IRE, radiation therapy or alcohol instillation) in the past 5 years.

Main reasons for not taking part

• Previous prostate treatment in the past 5 years
• Acute urinary tract infection
• Use of 5-alpha reductase inhibitors
• MRI of the prostate done outside Kantonsspital Aarau

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 45 and 80 years old?YesNo

What the trial wants to find out

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.

Treatments tested

• Proclarix®