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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. (see Contacts and Locations)
Verified May 2013 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01566045
First received: February 22, 2012
Last updated: May 28, 2013
Last verified: May 2013

February 22, 2012
May 28, 2013
May 2012
April 2015   (final data collection date for primary outcome measure)
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.
Prostate Cancer Diagnosis, Comparison of Biopsy techniques [ 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.
Complete list of historical versions of study NCT01566045 on ClinicalTrials.gov Archive Site
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MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study

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.

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.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
  • 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)
  • 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
  • Active Comparator: Core Needle TRUS biopsy (Transrectal ultrasound)
    Patient receiving core needle TRUS biopsy (Standard of care biopsy)
    Intervention: Procedure: Core Needle 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
    Intervention: Procedure: Core Needle MRI/US image fusion guided needle biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
980
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact: Art Rastinehad, MD arastine@NSHS.edu
Contact: Daniel Ziskind daniel.ziskind@philips.com
United States
 
NCT01566045
02072012
Yes
Philips Healthcare
Philips Healthcare
Not Provided
Not Provided
Philips Healthcare
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP