Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
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
Key facts
- Study ID
- NCT01964638
- Run by
- NYU Langone Health
- People needed
- 126
- Starts
- 2012-06-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2013-10-17
Who can join
Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- NYU Smilow Prostate Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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