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NCT Number: NCT01357512

Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

40 year–72 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio <=0.15, or total PSA 10-20 ng/ml)
  • PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
  • No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)

Exclusion criteria

  • Previous prostate biopsies
  • Previous prostate surgery
  • Contraindication for MRI (such as pacemaker or inner ear implant)
  • Claustrophobia
  • Estimated glomerular filtration rate (eGFR) <40 ml/min
  • Suspected clinical T3-T4 prostate cancer based on digital rectal examination
  • Contraindication for transrectal ultrasound-guided prostate biopsies
  • body mass index >30

Treatment and study plan

magnetic resonance imaging, Siemens

Device

Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device

Primary outcomes

  1. Number of Prostate Cancer Diagnoses in MRI and no MRI Groups

    Time frame: at the end of the study (up to 1 year)

    The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.

Secondary outcomes

  1. Number of Positive Biopsies in MRI and no MRI Groups

    Time frame: at the end of the study (up to 1 year)

    The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.

  2. Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups

    Time frame: at the end of the study (up to 1 year)

    Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer

Important dates

Study start
2011
Primary completion
2014
Study completion
2017
First posted
May 20, 2011
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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