Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.

Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01964638

Enrollment

126

Registered

2013-10-17

Start date

2012-06-30

Completion date

2013-03-31

Last updated

2013-10-17

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Prostate Biopsy, Targeted Biopsy

Brief summary

This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas

Interventions

PROCEDURETargeted Biopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* No previous diagnosis of adenocarcinoma of the prostate * No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations) * Active urinary tract infection

Exclusion criteria

* Prior pelvic radiotherapy * Prior androgen deprivation therapy * Evidence urinary tract infection or significant urinary retention * Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI. * Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of rates of prostate cancer diagnosis	One week after biopsy	The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.

Secondary

Measure	Time frame	Description
Evaluation of Rate of cancer diagnosis using targeted biopsy	One week after biopsy	The secondary endpoint of the study is the evaluation of the rate of cancer diagnosis using targeted biopsy (software or cognitive targeting) as compared to standard of care prostate biopsy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026