Know Cancer

forgot password

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

40 Years
72 Years
Open (Enrolling)
Prostatic Neoplasms

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Proportion of prostate cancer diagnoses in MRI and no MRI groups

Outcome Description:

Number of patients with suspicious findings in MRI leading to confirmation of prostate cancer in biopsies from suspected areas of prostate are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI.

Outcome Time Frame:

at the end of the study (up to 1 year)

Safety Issue:


Principal Investigator

Markku Vaarala, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oulu University Hospital


Finland: National Supervisory Authority for Welfare and Health

Study ID:




Start Date:

April 2011

Completion Date:

December 2016

Related Keywords:

  • Prostatic Neoplasms
  • prostate cancer diagnosis
  • magnetic resonance imaging
  • prostate biopsy
  • Neoplasms
  • Prostatic Neoplasms