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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357512
• Other study ID #: PRODIAMRI
• Status: Completed
• Phase: N/A
• First received: April 14, 2011
• Last updated: October 25, 2017
• Start date: April 2011
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Device:
• magnetic resonance imaging, Siemens
Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Prostate Cancer Diagnoses in MRI and no MRI Groups	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.	at the end of the study (up to 1 year)
Secondary	Number of Positive Biopsies in MRI and no MRI Groups	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.	at the end of the study (up to 1 year)
Secondary	Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups	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.	at the end of the study (up to 1 year)