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MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer

This study is currently recruiting participants.
Verified July 2012 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01566045
First received: February 22, 2012
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound)
Procedure: Core Needle MRI/US image fusion guided needle biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Number of prostate lesions [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    To determine if the number of prostate lesions identified by targeted (MR / US fusion biopsy) plus conventional biopsy is statitically greater than the number of lesions identified conventional biopsy alone. The number of positive lesions identified by both techniques will be compared.


Estimated Enrollment: 980
Study Start Date: May 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Core Needle TRUS biopsy (Transrectal ultrasound)
Patient receiving core needle TRUS biopsy (Standard of care biopsy)
 Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound)
Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate
Other Names:
  • Core Needle biopsy
  • TRUS needle biopsy (Transrectal ultrasound)
Experimental: Core Needle MRI/US fusion guided biopsy
Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy
 Procedure: Core Needle MRI/US image fusion guided needle biopsy
Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies
Other Names:
  • Core Needle biopsy
  • MRI/US image fusion guided needle biopsy

Detailed Description:

The efficacy of targeting lesions for surgery may be limited by the visibility of a target during the procedure. The successful outcome of surgical intervention depends upon accurate device placement, which may be very challenging in certain settings, such as when a kidney tumor only is visible for a brief moment during the transient arterial phase of a contrast injection, and soon disappearing on dynamic imaging.

Historically, prostate cancer was diagnosed by digitally guided trans-rectal prostate biopsies. With PSA (Prostate SPecific Antigen) screening and improvements in ultrasonography, trans-rectal ultrasound (TRUS) guided prostate biopsy have become the standard of care to screen and diagnose localized prostate cancer. Standard US 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients.

Prostate MR imaging with the addition of an endorectal-coil probe and a 3 Tesla magnet dramatically improves diagnostic utility dramatically but biopsies are difficult, time-consuming, and require specialized equipment, which increases the cost significantly.

To meet this challenge TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard 12-14 core biopsies.

This study will consist of comparison of the standard of care (TRUS guided prostate biopsy) with the protocol biopsy which consists of a TRUS guided prostate biopsy and a MR/US fusion tracked prostate biopsy. Each patient will act as their own control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/NIH MR prostate imaging guidelines.
  2. Age greater than 18 years.
  3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
  4. 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.
  5. Ability to tolerate conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia).
  6. PSA > 2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
  7. Pre-biopsy prostate MRI as described above, showing targetable lesions within 2 months of biopsy
  8. Able to tolerate a TRUS guided biopsy

Exclusion Criteria:

  1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
  2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
  3. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
  4. Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
  5. Patients with uncorrectable coagulopathies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566045

Contacts
Contact: Tara MacKinnon tara.mackinnon@philips.com

Locations
United States, New York
The Arthur Smith Institute for Urology Recruiting
New Hyde Park, New York, United States, 11040
Contact: Art Rastinehad, MD     516-734-8500     nycurology@gmail.com    
Principal Investigator: Ardeshir R Rastinehad, DO            
Sub-Investigator: David N Siegel, MD            
Sub-Investigator: Eran Ben-Levi, MD            
Sponsors and Collaborators
Philips Healthcare
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01566045     History of Changes
Other Study ID Numbers: 02072012
Study First Received: February 22, 2012
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Healthcare:
Prostate Cancer
Biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013