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

Launched by ARDESHIR RASTINEHAD · Oct 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect and measure prostate cancer using a technique called MRI/Ultrasound fusion biopsy. Researchers want to see if this method is better than the standard approach, which only uses ultrasound to guide the biopsy. The goal is to improve the accuracy of diagnosing significant prostate cancer in men who have certain risk factors, like elevated prostate-specific antigen (PSA) levels or abnormal results from a digital rectal exam.

To participate in this study, men aged 18 and older must have had a pre-operative MRI that shows specific areas of concern in the prostate. They should also be able to tolerate the procedure, which may involve sedation. Participants will undergo both the standard ultrasound-guided biopsy and the new MRI/ultrasound fusion biopsy. It's important to note that individuals with certain health conditions that affect their ability to understand the procedure or remain still during it may not be eligible. This trial aims to enhance the way prostate cancer is diagnosed, which could lead to better treatment options in the future.

Gender

MALE

Eligibility criteria

• 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.