MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer

NCT01566045 | Withdrawn DMC

• 1 other identifier: 02072012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 Cancer

Keywords

Prostate Cancer; Biopsy

Outcome Measures

Primary Outcomes (1)

• Number of prostate lesions

  To determine if the number of prostate lesions identified by targeted (MR / US fusion biopsy) plus conventional biopsy is statitically greater than the number of lesions identified conventional biopsy alone. The number of positive lesions identified by both techniques will be compared.

  Day 1

Study Arms (2)

Core Needle TRUS biopsy (Transrectal ultrasound)

ACTIVE COMPARATOR

Patient receiving core needle TRUS biopsy (Standard of care biopsy)

Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound)

Core Needle MRI/US fusion guided biopsy

EXPERIMENTAL

Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy

Procedure: Core Needle MRI/US image fusion guided needle biopsy

Interventions

Core Needle TRUS Needle biopsy (Transrectal ultrasound) PROCEDURE

Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate

Also known as: Core Needle biopsy, TRUS needle biopsy (Transrectal ultrasound)

Core Needle TRUS biopsy (Transrectal ultrasound)

Core Needle MRI/US image fusion guided needle biopsy PROCEDURE

Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies

Also known as: Core Needle biopsy, MRI/US image fusion guided needle biopsy

Core Needle MRI/US fusion guided biopsy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/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 conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia).
• 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 2 months of biopsy
• Able to tolerate a TRUS 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.
• Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
• Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
• Patients with uncorrectable coagulopathies.

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

The Arthur Smith Institute for Urology

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 29, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

US (1)