MRI-Guided Biopsy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a special needle holder frame can improve the accuracy of MRI-guided prostate biopsies. The goal is to determine if this new method can safely and effectively target suspicious areas in the prostate for sampling. Men with an abnormal PSA level (a blood test for prostate health) or a suspicious lump in their prostate might be suitable candidates for this study. Participants will undergo a routine MRI-guided biopsy using the experimental needle holder instead of the standard template. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance prostate biopsy techniques.
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 trial coordinators or your doctor.
What prior data suggests that this MRI-guided biopsy technique is safe for prostate cancer patients?
Research has shown that MRI-guided prostate biopsies are generally safe and well-tolerated. One study on MRI methods for men suspected of having prostate cancer found this approach both practical and safe, reporting no significant increase in complications with MRI-guided techniques. Another study found that combining MRI with ultrasound improved the accuracy of detecting important prostate cancer without increasing safety risks. These findings suggest that using MRI guidance in prostate biopsies does not lead to more adverse events compared to traditional methods. Overall, the evidence supports the safe use of MRI-guided biopsies in clinical settings.12345
Why are researchers excited about this trial?
The MRI-guided prostate biopsy is unique because it uses advanced imaging technology to precisely target areas in the prostate, potentially leading to more accurate diagnoses of prostate cancer. Traditional biopsies often use ultrasound guidance, which might miss cancerous areas due to less detailed imaging. This MRI-guided approach allows doctors to see the prostate in high detail and target specific areas, which could reduce the need for repeat biopsies and lower the risk of missing significant cancers. Researchers are excited about this method because it could improve diagnostic accuracy and patient outcomes by catching cancer earlier and more reliably.
What evidence suggests that this MRI-guided biopsy is effective for prostate cancer?
Research has shown that using MRI to guide prostate biopsies, which participants in this trial will receive, effectively finds prostate cancer. One study correctly identified cancer in 63 out of 110 patients, outperforming some traditional methods. Another study found that MRI-guided techniques detected significant cancer cases in about 28.6% of patients. Additionally, MRI use can help avoid unnecessary biopsies by reducing the diagnosis of non-threatening cancers by more than half. Overall, MRI-guided biopsies offer a promising approach to accurately detecting prostate cancer.678910
Who Is on the Research Team?
Kemal Tuncali, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for men over 30 with suspected prostate cancer, who have either an abnormal PSA level (>4ng/Ml), a palpable nodule on examination, or a suspicious lesion seen in prostate MRI. They must be able to consent and have no contraindications to MRI like pacemakers, inner ear implants, or certain brain aneurysm clips.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-procedure Consultation
Participants meet with the study physician to discuss anesthesia or sedation options prior to the biopsy procedure
MRI-guided Prostate Biopsy
Participants undergo the MRI-guided prostate biopsy using a needle holder frame to assess the feasibility of accurate tissue sampling
Follow-up
Participants are monitored for any immediate post-procedure complications and the accuracy of needle placement is assessed
What Are the Treatments Tested in This Trial?
Interventions
- MRI-guided Prostate Biopsy
Trial Overview
The study tests the feasibility of using a needle holder frame for MR-guided prostate biopsies. It aims to see if this new tool can accurately sample tissue from areas of concern identified by MRI during routine biopsy procedures.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants who receive biopsy under MRI-guidance and a needle holder frame.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Physical Sciences Inc.
Collaborator
Citations
Results after Four Years of Screening for Prostate Cancer ...
In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer.
Cost-Effectiveness of Annual Prostate MRI and Potential ...
Results from this study suggest that the MRI and potential MRI-guided biopsy strategy is cost-effective compared with standard biopsy for the ...
3.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/07110/clinical_value_of_transperineal_prostate_biopsy.56.aspxClinical value of transperineal prostate biopsy guided by...
Of 110 patients, 63 were confirmed with prostate cancer. The MRI–TRUS fusion-guided biopsy achieved a higher positive detection rate (54.55%) ...
Impact of MRI/US fusion‐guided prostate biopsy on biopsy ...
Results. The overall cancer detection rate was 75%:31% clinically significant, 44% favorable, and 25% no cancer. These findings triggered active ...
MRI/ultrasound fusion biopsy of the prostate compared to ...
Fusion-guided biopsy alone detected 227/524 (43.3%) and clinically significant cancer in 150/524 (28.6%) cases. A histological upgrade of the Gleason score by ...
Oncological Safety of MRI-Informed Biopsy Decision ...
This cohort study assesses the feasibility and safety of a community-based magnetic resonance imaging (MRI) diagnostic strategy in men with suspected prostate ...
Results after Four Years of Screening for Prostate Cancer ...
In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer.
Five-year Outcomes for Men after Negative Magnetic ...
The findings show that fewer than 1 in 13 men developed clinically significant (Grade Group = 2) prostate cancer, none developed metastases or ...
Prostate cancer detection and complications of MRI ...
This unique study, exclusively focusing on comparative research, indicates no significant differences in csPCa and iPCa detection rates between COG-TB, FUS-TB, ...
Optimizing Safety and Accuracy of Prostate Biopsy - PMC
Use of MRI – ultrasound fusion to guide biopsy results in increased detection of clinically significant prostate cancer (csCaP). (7,15,48,49) In the largest ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.