Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy
Status unconfirmed · Not applicable
Conditions studied: Prostate Cancer
In brief
Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging (mpMRI) is an imaging test that may improve prostate cancer detection rates in this population of men. In this prospective randomized trial multicenter trial the investigators will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared with the addition of either a computer targeted system (UroNav - InVivo corp) to sample suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these areas and systematic biopsy alone.
Key facts
- Study ID
- NCT02138760
- Run by
- Kaiser Permanente
- People needed
- 400
- Starts
- 2014-08-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2014-05-15
Who can join
Age: 30 and older, up to 79. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- PSA > 2.5 ng/ml (ages 30-50) or PSA > 4.0 ages (50-79)
- Patients with prior negative prostate biopsy
- Written informed consent
- Age > 30
You may not qualify if…
- Prior diagnosis of prostate cancer
- Age> 79
- No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies, anatomical contraindications)
- Active urinary tract infection or indwelling catheter
- Prior pelvic irradiation
- Prior androgen deprivation hormonal therapy
- Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8 weeks prior to mpMRI.
- Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with MRI)
Where it is running
- Kaiser Permanente Los Angeles (Sunset) — Los Angeles, California, United States
- Kaiser Permanente Riverside — Riverside, California, United States
Full record on ClinicalTrials.gov
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