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Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers (IMPROD)

This study has been completed.
University of Turku
Information provided by (Responsible Party):
Turku University Hospital Identifier:
First received: April 17, 2013
Last updated: January 20, 2016
Last verified: January 2016

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.

Condition Intervention
Prostate Cancer
Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)
Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging

Resource links provided by NLM:

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis [ Time Frame: 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:
  • Predictive value of molecular markers to estimate prostate cancer diagnosis. [ Time Frame: 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.

Enrollment: 175
Study Start Date: March 2013
Study Completion Date: November 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI
Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany) Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
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Please refer to this study by its identifier: NCT01864135

Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
University of Turku
Principal Investigator: Hannu J Aronen, MD, PhD Department of Diagnostic Radiology, University of Turku
  More Information

Responsible Party: Turku University Hospital Identifier: NCT01864135     History of Changes
Other Study ID Numbers: 112/180/2012
Study First Received: April 17, 2013
Last Updated: January 20, 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on May 25, 2017