Prostate CancerNCT03366792
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
A study testing Artemis™ software system in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Artemis™ software system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 26 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score >3/5)
Who cannot join
- Prior pelvic radiotherapy
- Evidence of urinary tract infection or significant urinary retention
- Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
- No evidence of suspicious lesions on mpMRI
- Irreversible coagulopathy
- Contraindication to sedation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.
Read the detailed description
Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.
- Conditions
- Prostate Cancer
- Being tested
- Artemis™ software system
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemis™ software systemDevice
Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
| Study group | Role | What they receive |
|---|---|---|
| MRI Targeted Biopsy | Experimental | Not described Receives: Device: Artemis™ software system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Cancer Length
Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)
Measured: 2 Months
Secondary outcomes (1)
Percentage of High-Grade Prostate Cancer Using Gleason Score
High-grade prostate cancer is defined as a Gleason score > 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.
Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start17 Oct 2017
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Why it stopped: Investigators chose to discontinue the study based on interim findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Taneja, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366792
- Sponsor's protocol ID
- 14-01550
- Status last verified
- Feb 2022
- First submitted
- 21 Nov 2017
- Last updated
- 23 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03366792
- Acronym / sponsor ID
- 14-01550
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators chose to discontinue the study based on interim findings
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Posted 23 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.
Detailed description
Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Targeted Biopsy | Experimental | Device: Artemis™ software system |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score >3/5)
Key exclusion criteria (6 listed)
- Prior pelvic radiotherapy
- Evidence of urinary tract infection or significant urinary retention
- Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
- No evidence of suspicious lesions on mpMRI
- Irreversible coagulopathy
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 |
|---|---|---|
| Artemis™ software systemComputerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging. | Device | MRI Targeted Biopsy |
Primary outcome
Core Cancer Length
Time frame: 2 Months
Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)
1 secondary outcome
Percentage of High-Grade Prostate Cancer Using Gleason Score
Time frame: 2 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Samir Taneja, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artemis™ software system in people with Prostate Cancer, run by NYU Langone Health 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Cancer Length (time frame: 2 Months). 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 23 Mar 2022.