Clinical trial NCT06302595: MRI Guided Prostate Biopsy
Official title: Magnetic Resonance Imaging Guided Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suspected Prostate Cancer
Keywords: prostate cancer
prostate biopsy
MR-guided prostate biopsy
targeted biopsy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Physical Sciences Inc.
First posted: 2024-03-12
Enrollment: 15
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Accuracy of needle placement
timeFrame: During the MRI-guided prostate biopsy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kemal Tuncali, MD
role: PRINCIPAL_INVESTIGATOR
References: