Prostate DiseaseNCT04599218
MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
A study testing Prostate Biopsy, MR US Fusion Guided Prostate Biopsy and MR/TRUS Fusion Guided Prostate Biopsy in people with Prostate Disease and Elevated Prostate Specific Antigen, run by Ardeshir Rastinehad at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer
- What is being tested?
- Prostate Biopsy, MR US Fusion Guided Prostate Biopsy and MR/TRUS Fusion Guided Prostate Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,586 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2020to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
- Age greater than 18 years.
- 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.
- Ability to tolerate sedation and or general anesthesia if required.
- PSA >1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
- Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
- Able to tolerate an ultrasound guided biopsy.
Who cannot join
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
- Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
- Patients with uncorrectable coagulopathies.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
The Smith Institute for Urology
Lake Success, New York, 11042
Cynthia Knauer, RN, 646-874-4733, cknauer1@northwell.edu
Peter Tricarico, ptricarico1@northwell.edu
- Recruiting
The Smith Institute for Urology at Lenox Hill
New York, New York, 10022
Ardeshir Rastinehad, DO, 212-434-6580, Arastine@northwell.edu
- Recruiting
Manhattan Eye, Ear, and Throat Hospital (MEETH)
New York, New York, 10065
Ardeshir Rastinehad, DO, 212-434-6580, Arastine@northwell.edu
About this study
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.
Read the detailed description
The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement.
Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.
Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.
- Conditions
- Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam, Prostate Cancer
- Being tested
- Prostate Biopsy, MR US Fusion Guided Prostate Biopsy, MR/TRUS Fusion Guided Prostate Biopsy
- Keywords
- Prostate Cancer, Prostate Biopsy, Prostate MRI, Targeted Prostate Biopsy, Fusion Biopsy
- Medical subject headings
- Prostatic Diseases, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate BiopsyOther
Also called Transperineal (TP) Prostate Biopsy, UroNav Fusion Biopsy, Targeted prostate biopsy, Ultrasound guided Prostate Biopsy
Standard of care
MR US Fusion Guided Prostate BiopsyOther
Also called Fusion Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) biopsy.
MR/TRUS Fusion Guided Prostate BiopsyDevice
TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Males with Prostate Cancer | Experimental | Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy. Receives: Other: Prostate Biopsy; Other: MR US Fusion Guided Prostate Biopsy; Device: MR/TRUS Fusion Guided Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Prostate Cancer
Incidence of diagnosing subjects with prostate cancer with MR visible lesions
Measured: 1 Month
Secondary outcomes (3)
Incidence of adverse events
the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy
Measured: 1 Month
Pirads score
The Prostate Imaging Reporting and Data System (PIRADS) score classifies MRI lesions on a scale from 1 to 5, which reflects their level of suspicion from least to most. Higher score indicates more suspicion.
Measured: 1 Month
Gleason score
The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Sum of the gleason grade of the most predominant tumor pattern and a second gleason grade of the second most predominant pattern. Full score from 2 to 10, with higher score indicating more clinically significance.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Aug 2020
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardeshir Rastinehad
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor-investigator, Ardeshir Rastinehad, Northwell Health
- Investigators
- Ardeshir Rastinehad, DO, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599218
- Sponsor's protocol ID
- 20-0384
- Status last verified
- Feb 2024
- First submitted
- 16 Oct 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
- ClinicalTrials.gov ID
- NCT04599218
- Acronym / sponsor ID
- 20-0384
- Conditions
- Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam, Prostate Cancer
- Keywords
- Prostate Cancer, Prostate Biopsy, Prostate MRI, Targeted Prostate Biopsy, Fusion Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,586 participants (estimated)
- Lead sponsor
- Ardeshir RastinehadUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 22 Oct 2020 (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 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.
Detailed description
The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement.
Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.
Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males with Prostate Cancer | Experimental | Other: Prostate Biopsy, Other: MR US Fusion Guided Prostate Biopsy, Device: MR/TRUS Fusion Guided Prostate BiopsyEach participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
- Age greater than 18 years.
- 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.
- Ability to tolerate sedation and or general anesthesia if required.
Key exclusion criteria (3 listed)
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
- Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
- Patients with uncorrectable coagulopathies.
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 |
|---|---|---|
| Prostate BiopsyAlso: Transperineal (TP) Prostate Biopsy, UroNav Fusion Biopsy, Targeted prostate biopsy, Ultrasound guided Prostate BiopsyStandard of care | Other | Males with Prostate Cancer |
| MR US Fusion Guided Prostate BiopsyAlso: Fusion BiopsyTrans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) biopsy. | Other | Males with Prostate Cancer |
| MR/TRUS Fusion Guided Prostate BiopsyTRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies. | Device | Males with Prostate Cancer |
Primary outcome
Incidence of Prostate Cancer
Time frame: 1 Month
Incidence of diagnosing subjects with prostate cancer with MR visible lesions
3 secondary outcomes
Incidence of adverse events
Time frame: 1 Month
Pirads score
Time frame: 1 Month
Gleason score
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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. This study is not recruiting at the moment.
Ardeshir Rastinehad, DO principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate Biopsy, MR US Fusion Guided Prostate Biopsy and MR/TRUS Fusion Guided Prostate Biopsy in people with Prostate Disease and Elevated Prostate Specific Antigen, run by Ardeshir Rastinehad at 3 sites 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 8 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ardeshir R Rastinehad, DO (212-434-6580, Arastine@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Prostate Cancer (time frame: 1 Month). 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 2 Feb 2024.