Clinical trial NCT04026763: MR/TRUS Fusion Guided Prostate Biopsy
Official title: MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Disease
Elevated Prostate Specific Antigen
Family History of Prostate Cancer
Positive Digital Rectal Exam
Keywords: Targeted Prostate Biopsy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2019-07-19
Enrollment: 520
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 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.

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 at 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 prostate biopsies.

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. Each patient will act as their own control.

Eligibility criteria: Inclusion Criteria:

* All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines.
* 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 and 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 \>2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
* Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
* Able to tolerate a 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 pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
* Patients with uncorrectable coagulopathies.

Primary outcomes:
measure: Incidence of Prostate Cancer
timeFrame: Day 0 - day of procedure
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: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ardeshir Rastinehad, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winoker JS, Wajswol E, Falagario U, Maritini A, Moshier E, Voutsinas N, Knauer CJ, Sfakianos JP, Lewis SC, Taouli BA, Rastinehad AR. Transperineal Versus Transrectal Targeted Biopsy With Use of Electromagnetically-tracked MR/US Fusion Guidance Platform for the Detection of Clinically Significant Prostate Cancer. Urology. 2020 Dec;146:278-286. doi: 10.1016/j.urology.2020.07.072. Epub 2020 Sep 18.