MR/TRUS Fusion Guided Biopsy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byArdeshir Rastinehad, DO
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ardeshir Rastinehad
Disqualifiers: Altered mental status, Coagulopathies, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment MR/TRUS Fusion Guided Biopsy for Prostate Cancer?
Research shows that using MRI and ultrasound together for prostate biopsies improves the detection of significant prostate cancer compared to using ultrasound alone. This combined approach helps find more high-grade cancers and reduces errors in sampling.
12345Is MR/TRUS Fusion Guided Biopsy for Prostate Cancer safe?
The research does not specifically address the safety of MR/TRUS Fusion Guided Biopsy, but it is a commonly used technique in prostate cancer diagnosis, suggesting it is generally considered safe. However, as with any medical procedure, there may be risks, and it is important to discuss these with your healthcare provider.
13456How is MR/TRUS Fusion Guided Biopsy different from other prostate cancer treatments?
MR/TRUS Fusion Guided Biopsy combines magnetic resonance imaging (MRI) with transrectal ultrasound (TRUS) to more accurately target and detect significant prostate cancer, improving detection rates compared to standard TRUS-guided biopsy alone.
12347Eligibility Criteria
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.Inclusion Criteria
I can undergo a biopsy with ultrasound guidance.
No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
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 more
Exclusion Criteria
I cannot stay still for long periods on a procedure table.
I have a blood clotting disorder that cannot be corrected.
Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Biopsy Procedure
Participants undergo both standard ultrasound guided prostate biopsy and MR/TRUS fusion guided prostate biopsy
1 day
1 visit (in-person)
Follow-up
Participants are monitored for adverse events and the effectiveness of the biopsy procedures
4 weeks
1 visit (in-person)
Participant Groups
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.
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.
MR/TRUS Fusion Guided Prostate Biopsy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as MRI/TRUS Fusion Guided Prostate Biopsy for:
- Diagnosis of clinically significant prostate cancer
- Detection of prostate cancer with MRI visible lesions
🇪🇺 Approved in European Union as MRI/TRUS Fusion Guided Prostate Biopsy for:
- Diagnosis of prostate cancer
- Detection of high-risk prostate cancer
🇨🇦 Approved in Canada as MRI/TRUS Fusion Guided Prostate Biopsy for:
- Diagnosis of clinically significant prostate cancer
- Detection of prostate cancer with MRI visible lesions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Smith Institute for UrologyLake Success, NY
The Smith Institute for Urology at Lenox HillNew York, NY
Manhattan Eye, Ear, and Throat Hospital (MEETH)New York, NY
Loading ...
Who Is Running the Clinical Trial?
Ardeshir RastinehadLead Sponsor
Philips HealthcareIndustry Sponsor
References
Trans-rectal ultrasound visibility of prostate lesions identified by magnetic resonance imaging increases accuracy of image-fusion targeted biopsies. [2022]To compare the diagnostic yield of targeted prostate biopsy using image-fusion of multi-parametric magnetic resonance (mp-MR) with real-time trans-rectal ultrasound (TRUS) for clinically significant lesions that are suspicious only on mp-MR versus lesions that are suspicious on both mp-MR and TRUS.
TRUS-MR Fusion Biopsy of the Prostate: Radiological and Histological Correlation. [2022]Targeted magnetic resonance/ultrasound fusion prostate biopsy has been shown to improve the detection of high-grade prostate cancer and to reduce sampling errors. Our objective is to assess MR-TRUS targeted fusion biopsy versus standard biopsy for the detection of clinically significant tumors.
Beyond transrectal ultrasound-guided prostate biopsies: available techniques and approaches. [2020]Recent advances have led to the use of magnetic resonance imaging (MRI) alone or with fusion to transrectal ultrasound (TRUS) images for guiding biopsy of the prostate. Our group sought to develop consensus recommendations regarding MRI-guided prostate biopsy based on currently available literature and expert opinion.
[Real-time MRI/US fusion-guided biopsy in biopsy-naïve and pre-biopsied patients with suspicion for prostate cancer]. [2022]Magnetic resonance imaging (MRI)/ultrasound (US) fusion-guided biopsy detects more prostate cancer (PCa) than transrectal US (TRUS)-guided biopsy in patients with an indication for prostate re-biopsy. The aim of this study was a) to compare the detection rates of MRI/US fusion-guided biopsy with conventional TRUS in a double centre cohort and b) to investigate the influence of the number of pre-biopsies on the PCa detection rate.
Documenting the location of systematic transrectal ultrasound-guided prostate biopsies: correlation with multi-parametric MRI. [2021]During transrectal ultrasound (TRUS)-guided prostate biopsies, the actual location of the biopsy site is rarely documented. Here, we demonstrate the capability of TRUS-magnetic resonance imaging (MRI) image fusion to document the biopsy site and correlate biopsy results with multi-parametric MRI findings. Fifty consecutive patients (median age 61 years) with a median prostate-specific antigen (PSA) level of 5.8 ng/ml underwent 12-core TRUS-guided biopsy of the prostate. Pre-procedural T2-weighted magnetic resonance images were fused to TRUS. A disposable needle guide with miniature tracking sensors was attached to the TRUS probe to enable fusion with MRI. Real-time TRUS images during biopsy and the corresponding tracking information were recorded. Each biopsy site was superimposed onto the MRI. Each biopsy site was classified as positive or negative for cancer based on the results of each MRI sequence. Sensitivity, specificity, and receiver operating curve (ROC) area under the curve (AUC) values were calculated for multi-parametric MRI. Gleason scores for each multi-parametric MRI pattern were also evaluated. Six hundred and 5 systemic biopsy cores were analyzed in 50 patients, of whom 20 patients had 56 positive cores. MRI identified 34 of 56 positive cores. Overall, sensitivity, specificity, and ROC area values for multi-parametric MRI were 0.607, 0.727, 0.667, respectively. TRUS-MRI fusion after biopsy can be used to document the location of each biopsy site, which can then be correlated with MRI findings. Based on correlation with tracked biopsies, T2-weighted MRI and apparent diffusion coefficient maps derived from diffusion-weighted MRI are the most sensitive sequences, whereas the addition of delayed contrast enhancement MRI and three-dimensional magnetic resonance spectroscopy demonstrated higher specificity consistent with results obtained using radical prostatectomy specimens.
A Randomized Controlled Trial To Assess and Compare the Outcomes of Two-core Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy. [2022]Prostate biopsy guided by computer-assisted fusion of magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) images (MRI group) has not yet been compared with 12-core random biopsy (RB; control group) in a randomized controlled trial (RCT).
Magnetic Resonance Imaging-Ultrasound Fusion-Guided Prostate Biopsy: Review of Technology, Techniques, and Outcomes. [2022]Transrectal ultrasound (TRUS)-guided (12-14 core) systematic biopsy of the prostate is the recommended standard for patients with suspicion of prostate cancer (PCa). Advances in imaging have led to the application of magnetic resonance imaging (MRI) for the detection of PCa with subsequent development of software-based co-registration allowing for the integration of MRI with real-time TRUS during prostate biopsy. A number of fusion-guided methods and platforms are now commercially available with common elements in image and analysis and planning. Implementation of fusion-guided prostate biopsy has now been proven to improve the detection of clinically significant PCa in appropriately selected patients.