Suspected Prostate CancerNCT06302595
MRI Guided Prostate Biopsy
A study testing MRI-guided prostate biopsy using the needle holder frame. in people with Suspected Prostate Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Suspected Prostate Cancer
- What is being tested?
- MRI-guided prostate biopsy using the needle holder frame.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either an abnormal serum prostate-specific antigen (PSA) level (> 4ng/Ml) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion..
- Diagnostic MRI of the prostate gland.
- Age > 30 years
- Signed informed consent.
- No contra-indications to MRI, i.e. no cardiac pacemaker.
- No recent or ongoing active ischemic heart disease.
Who cannot join
- Inability to give informed consent.
- Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips.
- Recent or ongoing active ischemic heart disease such as recent or ongoing angina.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kemal Tuncali, MD, 617-732-7631, ktuncali@bwh.harvard.edu
About this study
Official title: Magnetic Resonance Imaging Guided Prostate Biopsy
This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.
Read the detailed description
The study will be conducted during a routine MR-guided prostate biopsy procedure. The following protocol follows the workflow of the routine procedure, except that the needle holder frame is used in place of a conventional needle-guiding template. The treating physicians have decided that an MR-guided prostate biopsy is necessary under the participant's current condition. If the participant chooses to participate in this research study, the procedure will be done in an MR scanner with an investigational needle holder frame.
Before the MR-guided prostate biopsy, the participant already had a standard clinical prostate MRI, the images from which will be used during the procedure.
The MR-guided prostate biopsy procedure may require monitored anesthesia or sedation. The participant will meet with the study physician prior to the biopsy procedure. The study physician will decide the type of monitored anesthesia or sedation to be used in discussion with the participant.
When undergoing a study in the MRI system, the participant will lie motionless inside the gantry of the system. Occasionally, the machine will produce a loud banging noise, as if it were being pounded from the outside with a hammer. Earplugs are available to reduce this sound level.
While the participant is in the magnet, under the anesthetic, the study physician will do the biopsy. To do this, the study physician will use a needle holder frame, which will show us where to put the needle by lining up the correct place outside on the skin or rectal wall.
Like the routine procedure, the biopsy is done with a needle put through the skin under the participant's scrotum by the doctor. The location of the needle is confirmed by acquiring an MR image (confirmation image). Several biopsies are taken each time, from either side of the gland and from places where the MR images show shadows or abnormal areas. There can be a range of 6-15 locations to sample. Because the location of the needle is always confirmed on the confirmation image, like the routine procedure, the use of the needle holder frame will not compromise the sampling of MR-indicated abnormal areas. The participant will be in the study for about 1.5 hours, which is how long the biopsy procedure will take. After the procedure, the investigator will review the confirmation images to assess the accuracy of needle placement, though it will not change the health outcome (e.g., pathological findings).
- Conditions
- Suspected Prostate Cancer
- Being tested
- MRI-guided prostate biopsy using the needle holder frame.
- Keywords
- prostate cancer, prostate biopsy, MR-guided prostate biopsy, targeted biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided prostate biopsy using the needle holder frame.Device
A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions.
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided prostate biopsy | Experimental | Participants who receive biopsy under MRI-guidance and a needle holder frame. Receives: Device: MRI-guided prostate biopsy using the needle holder frame. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of needle placement
The number of biopsy failures (defined as the number of needle insertions that miss the target zone defined on MRI).
Measured: During the MRI-guided prostate biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start24 Aug 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Prostate CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Physical Sciences Inc.
- Responsible party
- Principal investigator, Kemal Tuncali, M.D., Brigham and Women's Hospital
- Investigators
- Kemal Tuncali, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302595
- Sponsor's protocol ID
- 2022P001093
- Other IDs
- 5R44CA224853
- Status last verified
- Dec 2025
- First submitted
- 15 Feb 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Guided Prostate Biopsy
- ClinicalTrials.gov ID
- NCT06302595
- Acronym / sponsor ID
- 2022P001093
- Conditions
- Suspected Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, MR-guided prostate biopsy, targeted biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Physical Sciences Inc.
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.
Detailed description
The study will be conducted during a routine MR-guided prostate biopsy procedure. The following protocol follows the workflow of the routine procedure, except that the needle holder frame is used in place of a conventional needle-guiding template. The treating physicians have decided that an MR-guided prostate biopsy is necessary under the participant's current condition. If the participant chooses to participate in this research study, the procedure will be done in an MR scanner with an investigational needle holder frame.
Before the MR-guided prostate biopsy, the participant already had a standard clinical prostate MRI, the images from which will be used during the procedure.
The MR-guided prostate biopsy procedure may require monitored anesthesia or sedation. The participant will meet with the study physician prior to the biopsy procedure. The study physician will decide the type of monitored anesthesia or sedation to be used in discussion with the participant.
When undergoing a study in the MRI system, the participant will lie motionless inside the gantry of the system. Occasionally, the machine will produce a loud banging noise, as if it were being pounded from the outside with a hammer. Earplugs are available to reduce this sound level.
While the participant is in the magnet, under the anesthetic, the study physician will do the biopsy. To do this, the study physician will use a needle holder frame, which will show us where to put the needle by lining up the correct place outside on the skin or rectal wall.
Like the routine procedure, the biopsy is done with a needle put through the skin under the participant's scrotum by the doctor. The location of the needle is confirmed by acquiring an MR image (confirmation image). Several biopsies are taken each time, from either side of the gland and from places where the MR images show shadows or abnormal areas. There can be a range of 6-15 locations to sample. Because the location of the needle is always confirmed on the confirmation image, like the routine procedure, the use of the needle holder frame will not compromise the sampling of MR-indicated abnormal areas. The participant will be in the study for about 1.5 hours, which is how long the biopsy procedure will take. After the procedure, the investigator will review the confirmation images to assess the accuracy of needle placement, though it will not change the health outcome (e.g., pathological findings).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided prostate biopsy | Experimental | Device: MRI-guided prostate biopsy using the needle holder frame.Participants who receive biopsy under MRI-guidance and a needle holder frame. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Either an abnormal serum prostate-specific antigen (PSA) level (> 4ng/Ml) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion..
- Diagnostic MRI of the prostate gland.
- Age > 30 years
- Signed informed consent.
- No contra-indications to MRI, i.e. no cardiac pacemaker.
Key exclusion criteria (3 listed)
- Inability to give informed consent.
- Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips.
- Recent or ongoing active ischemic heart disease such as recent or ongoing angina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-guided prostate biopsy using the needle holder frame.A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions. | Device | MRI-guided prostate biopsy |
Primary outcome
Accuracy of needle placement
Time frame: During the MRI-guided prostate biopsy procedure
The number of biopsy failures (defined as the number of needle insertions that miss the target zone defined on MRI).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kemal Tuncali, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-guided prostate biopsy using the needle holder frame. in people with Suspected Prostate Cancer, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kemal Tuncali, MD ((617) 732-7631, ktuncali@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of needle placement (time frame: During the MRI-guided prostate biopsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.