MR/TRUS Fusion Guided Biopsy for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Cynthia Knauer, RN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Ardeshir Rastinehad

Disqualifiers: Altered mental status, Coagulopathies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

1586 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MR/TRUS Fusion Guided Prostate Biopsy, which combines MRI and ultrasound, diagnoses significant prostate cancer more effectively than the usual ultrasound-only method. The trial focuses on men with an MRI indicating possible cancer spots who require a biopsy. Ideal participants have a PSA level higher than normal or an unusual prostate exam and can undergo MRI and ultrasound procedures. As an unphased trial, this study allows participants to contribute to advancing diagnostic methods for prostate cancer.

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 prior data suggests that this protocol is safe for prostate cancer diagnosis?

Research has shown that MRI/Ultrasound fusion-guided prostate biopsy is safe for patients. This outpatient procedure allows patients to go home the same day. The biopsy uses local anesthesia, numbing only the specific area being treated.

Studies have found that this method results in fewer complications than traditional methods. Patients generally tolerated the procedure well, with no major adverse events reported, indicating that serious side effects were rare.

Overall, this approach is considered safe and well-tolerated for diagnosing prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MR/TRUS Fusion Guided Biopsy for prostate cancer because it offers a more precise way to detect cancerous tissues. Unlike the standard ultrasound-guided biopsy, which can sometimes miss tumors, this technique combines MRI and ultrasound images to better target suspicious areas. This fusion method could lead to earlier and more accurate diagnosis, potentially catching aggressive cancers sooner and reducing the need for repeat biopsies. Overall, it represents a significant step forward in prostate cancer detection.

What evidence suggests that MR/TRUS Fusion Guided Biopsy is effective for diagnosing prostate cancer?

Research has shown that MRI/ultrasound fusion-guided prostate biopsy detects significant prostate cancer more effectively than the usual ultrasound-guided biopsy. Studies have found that this method identifies more critical cases of prostate cancer. By combining MRI images with live ultrasound, it achieves high accuracy. Some experts even refer to it as the "new gold standard" for prostate biopsies. This technique excels at detecting small but important cancers. Overall, it offers a more precise way to diagnose prostate cancer, aiding in better treatment planning. Participants in this trial will undergo both the standard ultrasound-guided biopsy and the MR/TRUS Fusion Guided prostate biopsy to assess the effectiveness of this advanced technique. ^{1 6 7 8 9}

Who Is on the Research Team?

Ardeshir Rastinehad, DO

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• MR/TRUS Fusion Guided Prostate Biopsy
• MR US Fusion Guided Prostate Biopsy
• Prostate Biopsy

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.

How Is the Trial Designed?

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 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

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04599218

NCT04599218 | MR/TRUS Fusion Guided Prostate Biopsy This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4928379/

Magnetic Resonance Imaging-Ultrasound Fusion-Guided ... Implementation of fusion-guided prostate biopsy has now been proven to improve the detection of clinically significant PCa in appropriately selected patients.

3. koelis.com koelis.com/us/blogs-details/mri-fusion-prostate-biopsy-the-new-gold-standard/

MRI Fusion Prostate Biopsy: The New Gold Standard The new gold standard is MRI fusion prostate biopsy, which uses MR images and fuses them with live ultrasound for a highly accurate biopsy.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X22002820

MRI/ultrasound fusion biopsy of the prostate compared to ... Fusion-guided biopsy can detect more cases of prostate cancers than systematic biopsy alone, especially clinically significant cancer.

5. ar.iiarjournals.org ar.iiarjournals.org/content/anticanres/37/6/3291.full-text.pdf

Multiparametric MRI/TRUS Fusion Prostate Biopsy Conclusion: Multiparametric MRI/TRUS TP in comparison to TR fusion biopsy detected a greater percentage of small but clinically significant PCa of the anterior ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01566045

MRI/TRUS Fusion Guided Prostate Biopsy- An Improved ... This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0302283821021357

Multiparametric Magnetic Resonance Imaging for the ... Transperineal MFGB can safely be performed as an outpatient procedure under local anesthesia in an ambulatory setting.

8. radiologyinfo.org radiologyinfo.org/en/info/prostate-biopsy

Ultrasound- and MRI-Guided Prostate Biopsy Current and accurate information for patients about prostate biopsy. Learn what you might experience, how to prepare for the procedure, benefits, risks and ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.880336/full

MRI/Transrectal Ultrasound Fusion-Guided Targeted ... Compared to traditional TRUS-guided biopsy, MRI-TB had a significantly higher detection rate of clinically significant PCa (RR=1.27; 95%CI 1.15- ...