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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.

Ability to tolerate sedation and or general anesthesia if required.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 can safely undergo sedation or general anesthesia if needed.

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I had a prostate MRI showing treatable lesions within the last 4 months.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Prostate Cancer

Secondary outcome measures

Gleason score

Incidence of adverse events

Pirads score

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.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Ardeshir RastinehadLead Sponsor

Philips HealthcareIndustry Sponsor

125 Previous Clinical Trials

280,740 Total Patients Enrolled

5 Trials studying Prostate Cancer

397 Patients Enrolled for Prostate Cancer

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

2 Trials studying Prostate Cancer

300 Patients Enrolled for Prostate Cancer

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

Prostate Cancer Research Study Groups: Males with Prostate Cancer

Prostate Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available slots for individuals to join this research?

"As displayed on clinicaltrials.gov, this research project is still actively recruiting participants - initially posted in August 2020 and amended by January 2022."

Answered by AI

Are there any limitations to the number of people taking part in this trial?

"Affirmative, clinicaltrials.gov attests to this medical trial's continued recruitment of participants. It was first published on August 21st 2020 and most recently updated on January 22nd 2022. A total of 1586 patients will be recruited from 3 distinct research sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ardeshir Rastinehad 2020. "MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04599218.