NCT04026763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

3.6 years

First QC Date

July 17, 2019

Last Update Submit

July 18, 2019

Conditions

Prostate DiseaseElevated Prostate Specific AntigenFamily History of Prostate CancerPositive Digital Rectal Exam

Keywords

Targeted Prostate Biopsy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Prostate Cancer

    Incidence of diagnosing subjects with prostate cancer with MR visible lesions

    Day 0 - day of procedure

Secondary Outcomes (3)

  • Incidence of adverse events

    1 month

  • Pirads score

    1 month

  • Gleason score

    1 month

Study Arms (1)

Males with Prostate Cancer

EXPERIMENTAL

Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy.

Procedure: prostate biopsyProcedure: MR US Fusion Guided Prostate BiopsyDevice: MR/TRUS Fusion Guided Prostate Biopsy

Interventions

prostate biopsyPROCEDURE

standard of care

Males with Prostate Cancer
MR US Fusion Guided Prostate BiopsyPROCEDURE

Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy

Also known as: Fusion Biopsy
Males with Prostate Cancer
MR/TRUS Fusion Guided Prostate BiopsyDEVICE

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.

Males with Prostate Cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 11101, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32956688DERIVED

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ardeshir Rastinehad, DO

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ardeshir Rastinehad, DO

CONTACT

212-241-4812art.rastinehad@mountsinai.org

Cynthia Knauer, RN, MS

CONTACT

212-241-0751cynthia.knauer@mountsinai.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology and Urology

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 19, 2019

Study Start

May 11, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

US(1)