MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
Withdrawn before enrolling · Not applicable
Conditions studied: Prostate Cancer
In brief
This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.
Key facts
- Study ID
- NCT01566045
- Run by
- Philips Healthcare
- People needed
- 0
- Starts
- 2012-05-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2021-04-28
Who can join
Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/NIH MR prostate imaging guidelines.
- Age greater than 18 years.
- No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
- The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
- Ability to tolerate conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia).
- PSA > 2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
- Pre-biopsy prostate MRI as described above, showing targetable lesions within 2 months of biopsy
- Able to tolerate a TRUS guided biopsy
You may not qualify if…
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
- Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
- Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
- Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
- Patients with uncorrectable coagulopathies.
Where it is running
- The Arthur Smith Institute for Urology — New Hyde Park, New York, United States
Full record on ClinicalTrials.gov
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