Clinical trial NCT04599218: MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
Official title: MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Disease
Elevated Prostate Specific Antigen
Family History of Prostate Cancer
Positive Digital Rectal Exam
Prostate Cancer
Keywords: Prostate Cancer
Prostate Biopsy
Prostate MRI
Targeted Prostate Biopsy
Fusion Biopsy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2020-10-22
Enrollment: 1586
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
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:

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. Patients with uncorrectable coagulopathies.

Primary outcomes:
measure: Incidence of Prostate Cancer
timeFrame: 1 Month
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1 Month
measure: Pirads score
timeFrame: 1 Month
measure: Gleason score
timeFrame: 1 Month
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: The Smith Institute for Urology
state: New York
city: New York
country: United States
facility: The Smith Institute for Urology at Lenox Hill
state: New York
city: New York
country: United States
facility: Manhattan Eye, Ear, and Throat Hospital (MEETH)
state: New York
Study officials:
affiliation: Northwell Health
name: Ardeshir Rastinehad, DO
role: PRINCIPAL_INVESTIGATOR
References: