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Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging


N/A
40 Years
85 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Hannu J Aronen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Diagnostic Radiology, University of Turku

Authority:

Finland: Ethics Committee

Study ID:

112/180/2012

NCT ID:

NCT01864135

Start Date:

June 2013

Completion Date:

April 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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