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

A

Ardeshir Rastinehad

Status

Enrolling

Conditions

Elevated Prostate Specific Antigen
Prostate Disease
Positive Digital Rectal Exam
Family History of Prostate Cancer
Prostate Cancer

Treatments

Device: MR/TRUS Fusion Guided Prostate Biopsy
Other: MR US Fusion Guided Prostate Biopsy
Other: Prostate Biopsy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04599218
20-0384

Details and patient eligibility

About

This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy.

Full description

The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement. 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.

Enrollment

1,586 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
  • 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 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 sedation and or general anesthesia if required.
  • PSA >1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
  • Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
  • Able to tolerate an ultrasound guided biopsy.

Exclusion criteria

  • 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
  • Patients with uncorrectable coagulopathies.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,586 participants in 1 patient group

Males with Prostate Cancer
Experimental group
Description:
Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.
Treatment:
Other: Prostate Biopsy
Other: MR US Fusion Guided Prostate Biopsy
Device: MR/TRUS Fusion Guided Prostate Biopsy

Trial contacts and locations

3

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Central trial contact

Cynthia Knauer, RN; Ardeshir R Rastinehad, DO

Data sourced from clinicaltrials.gov

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