MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
NCT ID: NCT04599218
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1586 participants
INTERVENTIONAL
2020-08-21
2026-01-15
Brief Summary
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Detailed Description
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Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.
Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Males with Prostate Cancer
Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.
Prostate Biopsy
Standard of care
MR US Fusion Guided Prostate Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) biopsy.
MR/TRUS Fusion Guided Prostate Biopsy
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 prostate biopsies.
Interventions
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Prostate Biopsy
Standard of care
MR US Fusion Guided Prostate Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) biopsy.
MR/TRUS Fusion Guided Prostate Biopsy
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 prostate biopsies.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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 sedation and or general anesthesia if required.
6. PSA \>1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
7. Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
8. Able to tolerate an ultrasound guided biopsy.
Exclusion Criteria
2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
3. Patients with uncorrectable coagulopathies.
18 Years
MALE
No
Sponsors
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Philips Healthcare
INDUSTRY
Ardeshir Rastinehad
OTHER
Responsible Party
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Ardeshir Rastinehad
Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer
Principal Investigators
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Ardeshir Rastinehad, DO
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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The Smith Institute for Urology
Lake Success, New York, United States
The Smith Institute for Urology at Lenox Hill
New York, New York, United States
Manhattan Eye, Ear, and Throat Hospital (MEETH)
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-0384
Identifier Type: -
Identifier Source: org_study_id
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