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) ?

In men referred to a urologist with a high or concerning prostate specific antigen (PSA), can 3T multi-parametric MRI of the prostate be used as a triage for reducing the need to biopsy patients?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001137886

Enrollment

225

Registered

2012-10-25

Start date

2012-06-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is evaluating a novel diagnostic technique for prostate cancer, known as multi-parametric magnetic resonance imaging (mpMRI). Who is it for? You may be eligible to join this study if you are a male who has been referred to a urologist with a high or concerning PSA (Prostate-specific antigen), or abnormal prostatic rectal examination. Trial details All participants in this study will undergo current treatment guidelines for diagnosis of prostate cancer, including PSA measurements and 12 core Transrectal ultrasound (TRUS) guided needle biopsies of the prostate. In addition, a highly specific imaging process, known as multi-parametric magnetic resonance imaging (multiparametric MRI or mpMRI), will be used to further assess the prostate gland and be used to take MRI guided biopsy of any MRI detected lesions. This examination takes 20-30 minutes and involves the administration of a gadolinium contrast agent. It is anticipated that the results of this study will lead to better informed treatment of prostate cancer and suspected prostate cancer, for example by decreasing the number of men who need biopsies, decreasing the number of biopsy cores in those men who need them from 12 to 2 or 3, and decreasing the overtreatment of non-significant prostate cancer

Interventions

a) Single treatment arm b) multi-parametric MRI (mpMRI) prostate followed either by MRI prostate biopsy and ultrasound prostate biopsy; OR ultrasound prostate biopsy alone Decision to perform MRI guided biopsy is based on MRI findings using PIRADS scoring system (Eur Radiol. 2012 Apr;22(4):746-57. Epub 2012 Feb 10. ) - PIRADS 1 and 2 scored MRI patients only have TRUS biopsy - patients with MRI scored 3,4 or 5 have both an MRI guided biopsy and TRUS biopsy c) MRI prostate - 30min; MRI prostate

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

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)

Outcome results