Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer with Combination of PSA/DRE and Multi Parametric Magnetic Resonance Imaging

Launched by HEINRICH-HEINE UNIVERSITY, DUESSELDORF · Aug 5, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to diagnose clinically significant prostate cancer in men aged 50 to 75 who have an elevated prostate-specific antigen (PSA) level of 4 ng/ml or higher and/or suspicious results from a digital rectal exam (DRE). The study aims to combine a blood test (PSA), a physical examination (DRE), and a special type of imaging called multiparametric MRI to better identify prostate cancer. Men who qualify will first receive an MRI, and only those with results suggesting significant cancer will undergo a biopsy. Participants will be randomly assigned to one of two groups: one group will have a targeted biopsy based on the MRI, while the other will have a more comprehensive biopsy approach.

If you're a man aged 50 to 75 with an elevated PSA or a suspicious DRE, you might be eligible to participate in this trial. If selected, you can expect to have an MRI and, depending on the results, a biopsy to check for cancer. The trial is designed to reduce the number of unnecessary biopsies and treatment for less aggressive cancers, ultimately aiming to improve patient care and reduce healthcare costs. This study is not yet recruiting participants, but it seeks to make a positive impact on how prostate cancer is diagnosed and treated.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Men aged from 50 to 75 years
• • elevated PSA ≥ 4 ng/ml and/or cancer suspicious DRE
• Exclusion Criteria:
• • Men with known prostate cancer
• • men with prior prostate biopsy
• • men with non-MRI compatible devices
• • men with acute prostatitis