Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers
- Conditions
- Prostate Cancer
- Interventions
- Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
- Registration Number
- NCT01864135
- Lead Sponsor
- Turku University Hospital
- Brief Summary
Prostate cancer has been the most common cancer in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.
This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 175
- Age: 40 to 85 years
- Clinical suspicion of prostate cancer based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
- previous prostate biopsy in the last 6 months
- previous diagnosis of prostate carcinoma
- previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
- symptomatic of acute prostatitis
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- uncontrolled serious infection
- claustrophobia
- any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRI 3T MRI (Magnetom Verio 3T, Erlangen, Germany) Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies MRI Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system) Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis 3 months Multiparametric MRI is performed in patients with clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.
- Secondary Outcome Measures
Name Time Method Predictive value of molecular markers to estimate prostate cancer diagnosis. 3 months molecular markers include PCR-analyses of multiple markers from biopsy material. The association of molecular marker status is used to estimate the risk of prostate cancer on biopsies.
Trial Locations
- Locations (1)
Turku University Hospital
🇫🇮Turku, Finland