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MR/TRUS Fusion Guided Biopsy for Prostate Cancer

N/A
Recruiting
Led By Ardeshir Rastinehad, DO
Research Sponsored by Ardeshir Rastinehad
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to tolerate an ultrasound guided biopsy.
All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
Must not have
Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
Patients with uncorrectable coagulopathies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether MRI/US fusion biopsy is better than standard ultrasound biopsy for diagnosing subjects with clinically significant prostate cancer.

Who is the study for?
Men over 18 with a PSA level above 1.8, abnormal digital rectal exam results, or advised to have a biopsy can join this study if they're able to undergo sedation or anesthesia and have an MRI showing lesions within the past 4 months. They must be well enough to make informed decisions and agree to follow the study rules.
What is being tested?
The trial is testing whether combining MRI with ultrasound (MR/US fusion) for prostate biopsies is more effective at detecting significant prostate cancer compared to standard ultrasound-guided biopsies alone in men who show potential signs of prostate cancer on MRI scans.
What are the potential side effects?
Potential side effects from the biopsy procedure may include discomfort, bleeding, infection risk at the biopsy site, and reactions related to sedation or anesthesia used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can undergo a biopsy with ultrasound guidance.
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I have had a pre-op MRI following specific prostate imaging guidelines.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot stay still for long periods on a procedure table.
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I have a blood clotting disorder that cannot be corrected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Prostate Cancer
Secondary study objectives
Gleason score
Incidence of adverse events
Pirads score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Males with Prostate CancerExperimental Treatment3 Interventions
Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.

Find a Location

Who is running the clinical trial?

Ardeshir RastinehadLead Sponsor
Philips HealthcareIndustry Sponsor
126 Previous Clinical Trials
198,429 Total Patients Enrolled
Ardeshir Rastinehad, DO4.543 ReviewsPrincipal Investigator - Northwell Health
Medical School - New York Institute of Technology, New York College of Osteopathic Medicine, Doctor of Osteopathic Medicine
3 Previous Clinical Trials
820 Total Patients Enrolled
5Patient Review
great doc. would recommend to a friend.

Media Library

MR/TRUS Fusion Guided Prostate Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04599218 — N/A
Digital Rectal Exam Research Study Groups: Males with Prostate Cancer
Digital Rectal Exam Clinical Trial 2023: MR/TRUS Fusion Guided Prostate Biopsy Highlights & Side Effects. Trial Name: NCT04599218 — N/A
MR/TRUS Fusion Guided Prostate Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599218 — N/A
~260 spots leftby Oct 2025
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