Improved method for detecting and quantifying prostate cancer using MRI and ultrasound fusion biopsy
MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
This study is testing if a new way of combining MRI and ultrasound for prostate biopsies can find cancer better than the standard ultrasound method for men with high PSA levels or abnormal exams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1586 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Northwell Health Academic / other |
| Locations | 3 sites (Lake Success, New York and 2 other locations) |
| Trial ID | NCT04599218 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy against the standard ultrasound-guided biopsy for diagnosing clinically significant prostate cancer. Participants will undergo both types of biopsies to assess which method provides better detection of cancerous lesions. The study will focus on patients with elevated prostate-specific antigen (PSA) levels or abnormal digital rectal exams, utilizing advanced imaging techniques to enhance biopsy accuracy. The goal is to improve diagnostic outcomes for prostate cancer through more precise targeting of suspicious areas.
Who should consider this trial
Good fit: Ideal candidates include men over 18 with elevated PSA levels or abnormal digital rectal exams who have undergone a pre-operative MRI showing targetable lesions.
Not a fit: Patients with altered mental status or serious concurrent medical illnesses that prevent informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of prostate cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with MRI/US fusion biopsy techniques, indicating potential for improved diagnostic accuracy in prostate cancer detection.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lake Success, New York and 2 other locations
- The Smith Institute for Urology — Lake Success, New York, United States (Recruiting)
- The Smith Institute for Urology at Lenox Hill — New York, New York, United States (Recruiting)
- Manhattan Eye, Ear, and Throat Hospital (MEETH) — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ardeshir Rastinehad, DO — Northwell Health
- Study coordinator: Ardeshir R Rastinehad, DO
- Email: Arastine@northwell.edu
- Phone: 212-434-6580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.