Recruiting

Prostate Biopsy

Sponsor:

Ardeshir Rastinehad

Code:

NCT04599218

Conditions

Prostate Disease

Elevated Prostate Specific Antigen

Family History of Prostate Cancer

Positive Digital Rectal Exam

Prostate Cancer

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 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.

Conditions

Prostate Disease

Elevated Prostate Specific Antigen

Family History of Prostate Cancer

Positive Digital Rectal Exam

Prostate Cancer

Study ID

NCT04599218

Start date

Aug 21, 2020

Status verified date

Feb, 2024

Completion date

Jan 15, 2026

Anticipated

Primary completion date

Oct 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1586 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 ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.

Interventions

Prostate Biopsy

Standard of care

MR US Fusion Guided Prostate Biopsy

Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) 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: 1 Month ]

Central Contacts and Locations

Central contacts

Locations

The Smith Institute for Urology

Recruiting

Lake Success, New York, United States, 11042

Contacts

The Smith Institute for Urology at Lenox Hill

Recruiting

New York, New York, United States, 10022

Contacts

Manhattan Eye, Ear, and Throat Hospital (MEETH)

Recruiting

New York, New York, United States, 10065

Contacts

More Information

Sponsor

Ardeshir Rastinehad

Last update posted

Feb 2, 2024

Last verified

Feb, 2024

Keywords

  • Prostate Cancer
  • Prostate Biopsy
  • Prostate MRI
  • Targeted Prostate Biopsy
  • Fusion Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ardeshir Rastinehad on 2024-02-02.