Recruiting

Prostate Biopsy

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT04026763

Conditions

Prostate Disease

Elevated Prostate Specific Antigen

Family History of Prostate Cancer

Positive Digital Rectal Exam

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

prostate biopsy

MR US Fusion Guided Prostate Biopsy

MR/TRUS Fusion Guided Prostate Biopsy

Study Details

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.

Conditions

Prostate Disease

Elevated Prostate Specific Antigen

Family History of Prostate Cancer

Positive Digital Rectal Exam

Study ID

NCT04026763

Start date

May 11, 2018

Status verified date

Jul, 2019

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

520 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Males with Prostate Cancer

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.

Interventions

prostate biopsy

standard of care

MR US Fusion Guided Prostate Biopsy

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

Primary outcome measure

  • Incidence of Prostate Cancer [ Time Frame: Day 0 - day of procedure ]

Central Contacts and Locations

Central contacts

Ardeshir Rastinehad, DO

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

Cynthia Knauer, RN, MS

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

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 11101

Principal Investigator:

Ardeshir Rastinehad

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 19, 2019

Last verified

Jul, 2019

Keywords

  • Targeted Prostate Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2019-07-19.