Short summary

More than 4000 Danish men are diagnosed with prostate cancer each year. However, for more than half of the patients, the cancer will never become aggressive or life threatening, resulting in a high number of patients undergoing an unnecessary painful biopsy. By using a new algorithm, we aim to predict if the cancer becomes aggressive, based on specific biomarker levels in the patient's blood an urine samples, and thereby identify high-risk patients who will benefit from biopsies.

Rationale

Prostate cancer (PCa) affects more than 40,000 men in Denmark and each year more than 4,000 men are diagnosed with PCa. However, for more than half of the newly diagnosed patients, the cancer will never become aggressive or life threatening and the patients will not benefit from going through painful biopsies. In addition, men with an elevated prostate-specific antigen (PSA) serum level are also biopsied primarily based on this, resulting in a high number of patients undergoing an unnecessary biopsy. Unfortunately, prostate biopsy is not without potential complications, which include discomfort, pain, bleeding, and infections ranging from cystitis to septic sepsis and even death. Bleeding has been reported in 6-13% of patients undergoing prostate biopsy, while 0.3-4% experience admission with sepsis.

We recently reported the ability to predict the presence of aggressive PCa (Gleason score ≥7) using a combination of biomarkers detected in urine and peripheral blood plasma together with an algorithm, which incorporates the clinical data. With this study, we want to compare this form of "Liquid Biopsy", defined by our blood and urine panel, against standard prostate biopsy in a large-scale randomized manner including men referred for a biopsy due to the suspicion of prostate cancer over the age of 70.

A cohort of elderly men only is of particular interest, since PCa is primarily a cancer found in elderly men, but the main part of the elderly men will not benefit of the prostate cancer diagnose due to the indolent nature of the majority of prostate cancer. By performing this non-invasive test we expect that we can reduce need for prostate biopsy and reduce the detection of patients with an indolent prostate cancer (defined by Gleason score ≤ 6). Thereby we aim to reduce the side effects of biopsies and side effects of living with an indolent cancer.

Description of the cohort

We plan to include 700 elderly men (> 70 years old) refered to Department of Urology, Odense Universityhospital.

Data and biological material

Demographics and disease related data from the first visit and until the end of the follow up period of 20 years (such as dates and histology from biopsies, Gleason score, PSA measurements, size of the prostate, tumor stage, tumor progression and treatment). Blood and urine samples will be collected at the first visit. Questionnaires regarding disease related complications and life quality will be used. Data from the national registries (cause of death) will be used if needed.