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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Turku University Hospital
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01864135
First received: April 17, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (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)

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 biopsies
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864135

Contacts
Contact: Hannu J Aronen, MD, PhD +358-2-3133896 hannu.aronen@utu.fi
Contact: Peter Boström, MD, PhD +358-2-3135925 peter.bostrom@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Hannu J Aronen, MD, PhD    +358-2-3133896    hannu.aronen@utu.fi   
Contact: Peter Boström, MD, PhD    +358-2-3135925    peter.bostrom@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
University of Turku
Investigators
Principal Investigator: Hannu J Aronen, MD, PhD Department of Diagnostic Radiology, University of Turku
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01864135     History of Changes
Other Study ID Numbers: 112/180/2012
Study First Received: April 17, 2013
Last Updated: September 12, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014