MR/TRUS Fusion Guided Biopsy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Ardeshir 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. ^{1 2 3 4 5}

Is 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. ^{1 3 4 5 6}

How 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. ^{1 2 3 4 7}

Research Team

Ardeshir Rastinehad, DO

Principal Investigator

Northwell Health

Eligibility 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.

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)

Treatment Details

Interventions

• MR/TRUS Fusion Guided Prostate Biopsy (Device)
• MR US Fusion Guided Prostate Biopsy (Imaging)
• Prostate Biopsy (Procedure)

Trial Overview 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.

Participant Groups

Group I: Males with Prostate Cancer Experimental Treatment 3 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 Canada for the following indications:

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

Who Is Running the Clinical Trial?

Ardeshir Rastinehad

Lead Sponsor

Trials

1

Recruited

1,600+

Philips Healthcare

Industry Sponsor

Trials

127

Recruited

200,000+

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Findings from Research

Targeted biopsies using MR-TRUS fusion imaging significantly improved the detection rates of clinically significant prostate cancer (sPCa) compared to systematic biopsies, with detection rates of 61% versus 41%.

Highly suspicious lesions identified on mp-MR and visible on TRUS correlated with higher biopsy yields and greater cancer characteristics, indicating that TRUS visibility enhances the effectiveness of targeted biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-rectal ultrasound visibility of prostate lesions identified by magnetic resonance imaging increases accuracy of image-fusion targeted biopsies. Ukimura, O., Marien, A., Palmer, S., et al.[2022]

In a study of 102 men, MR-TRUS fusion biopsy detected a higher percentage of high-grade prostate cancers (Gleason 7 or higher) compared to standard random biopsy, improving the accuracy of cancer diagnosis.

While the overall detection rates of prostate cancer were similar between the two methods (44.1% for fusion biopsy vs. 42.4% for standard biopsy), fusion biopsy resulted in fewer low-grade tumors being identified, indicating a more targeted approach to diagnosing clinically significant tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TRUS-MR Fusion Biopsy of the Prostate: Radiological and Histological Correlation. Lavaerts, M., De Wever, L., Vanhoutte, E., et al.[2022]

MRI-guided prostate biopsies, with or without transrectal ultrasound (TRUS) fusion, can reduce unnecessary biopsies and improve the detection of high-risk prostate cancers that may be missed by standard TRUS biopsies.

While template mapping biopsy is the most accurate for assessing tumor volume and grade, it has a higher incidence of side effects compared to TRUS biopsy, indicating a trade-off between accuracy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond transrectal ultrasound-guided prostate biopsies: available techniques and approaches. Warlick, C., Futterer, J., Maruf, M., et al.[2020]

MRI/ultrasound fusion-guided biopsy detected prostate cancer in 69.7% of cases, significantly outperforming conventional transrectal ultrasound biopsy, which had a lower detection rate for clinically significant cancers.

Patients with multiple pre-biopsies tended to have lower Gleason scores, indicating that prior biopsies may influence the aggressiveness of detected cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Real-time MRI/US fusion-guided biopsy in biopsy-naïve and pre-biopsied patients with suspicion for prostate cancer]. Maxeiner, A., Stephan, C., Fischer, T., et al.[2022]

The study involved 50 patients undergoing TRUS-guided prostate biopsies, demonstrating that TRUS-MRI image fusion can effectively document biopsy sites and correlate them with MRI findings, enhancing the accuracy of cancer detection.

Multi-parametric MRI showed a sensitivity of 60.7% and specificity of 72.7% in identifying cancerous biopsy cores, with T2-weighted MRI and diffusion-weighted MRI being the most effective sequences for detecting positive cores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Documenting the location of systematic transrectal ultrasound-guided prostate biopsies: correlation with multi-parametric MRI. Turkbey, B., Xu, S., Kruecker, J., et al.[2021]

In a randomized controlled trial involving 175 biopsy-naïve patients, the detection rates of clinically significant prostate cancer (csPCa) were similar between MRI/TRUS-guided targeted biopsy and traditional 12-core random biopsy, indicating that both methods are effective for cancer detection.

The study found that two-core targeted biopsy using MRI/TRUS detected 87% of csPCa cases identified in the MRI group, suggesting that this targeted approach could potentially replace the more invasive 12-core random biopsy without compromising detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Baco, E., Rud, E., Eri, LM., et al.[2022]

Fusion-guided prostate biopsy, which combines MRI with real-time transrectal ultrasound (TRUS), has been shown to significantly improve the detection of clinically significant prostate cancer in selected patients.

This method enhances the standard 12-14 core systematic biopsy approach, making it a more effective option for diagnosing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Ultrasound Fusion-Guided Prostate Biopsy: Review of Technology, Techniques, and Outcomes. Kongnyuy, M., George, AK., Rastinehad, AR., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Trans-rectal ultrasound visibility of prostate lesions identified by magnetic resonance imaging increases accuracy of image-fusion targeted biopsies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

TRUS-MR Fusion Biopsy of the Prostate: Radiological and Histological Correlation. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Beyond transrectal ultrasound-guided prostate biopsies: available techniques and approaches. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Real-time MRI/US fusion-guided biopsy in biopsy-naïve and pre-biopsied patients with suspicion for prostate cancer]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Documenting the location of systematic transrectal ultrasound-guided prostate biopsies: correlation with multi-parametric MRI. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Ultrasound Fusion-Guided Prostate Biopsy: Review of Technology, Techniques, and Outcomes. [2022]