Can 3-Tesla Magnetic Resonance imaging of the prostate be useful in making the decision to perform prostate biopsy in men with a high or concerning prostate specific antigen (PSA) ?

Not Applicable

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12612001137886
• Lead Sponsor: The Wesley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 225

Inclusion Criteria

1. Men referred to a urologist with a high or concerning PSA, or abnormal prostatic rectal examination. These men would normally proceed to TRUS biopsy under current guidelines.

Exclusion Criteria

1. Men who have had a TRUS biopsy in the past
2. Men taking 5 alpha reductase inhibitors.
3. Men who are unwilling or unfit to undergo prostate biopsies (in the opinion of the referring urologist)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Accuracy in detection of the most aggressive prostate cancer present for mpMRI and mpMRI-guided biopsies vs. TRUS-guided biopsies for all patients by comparing biopsy results of mpMRI biopsies against TRUS guided biopsies in each patient with PIRADS score 3,4 or 5. For Patients with PIRADS score 1,2 only the mpMRI images will be compared to the biopsy results of the TRUS guided biopsies[At conclusion of study];2. Analysis of the number of biopsy cores taken to achieve diagnosis[At conclusion of study];3. Assess the detection or exclusion of indolent (insignificant) cancer by mpMRI and biopsy vs TRUS guided biopsy[At conclusion of study]

Secondary Outcome Measures

Name	Time	Method
Subgroup analysis comparing mpMRI vs TRUS in patients with :<br>1. Palpable vs non-palpable disease<br>2. Different PSA quartiles eg PSA 0-2.5, 2.5-5, 5-10, over 10[At conclusion of study]