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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01864135
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : January 21, 2016
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Turku University Hospital

Tracking Information
First Submitted Date  ICMJE April 17, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01864135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers
Official Title  ICMJE Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging
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 Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)
  • Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
Study Arms 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
Interventions:
  • Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)
  • Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)
175
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2013)
150
Actual Study Completion Date November 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01864135
Other Study ID Numbers  ICMJE 112/180/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Turku University Hospital
Study Sponsor  ICMJE Turku University Hospital
Collaborators  ICMJE University of Turku
Investigators  ICMJE
Principal Investigator: Hannu J Aronen, MD, PhD Department of Diagnostic Radiology, University of Turku
PRS Account Turku University Hospital
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP