Prostate CancerNCT07516808
PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy
A study testing Nonlinear Microscope (NLM) in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Nonlinear Microscope (NLM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to 28 Aug 2027
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Male or assigned male at birth (AMAB).
- Initial diagnosis of localized PrCa.
- Undergoing radical prostatectomy at BIDMC as part of their standard of care.
Who cannot join
- No short-form available in the participant's language.
- Cognitively unable to provide consent, in the opinion of the investigator.
- Patients with evidence of unequivocal radiologic bilateral extraprostatic extension (EPE) on most recent MRI results.
- Patients with >80 cc prostate volume (larger prostates would require potentially excessive evaluation time).
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
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
Peter Chang, MD, 617-667-3739, pchang@bidmc.harvard.edu
About this study
This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.
Read the detailed description
This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind.
The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses.
The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery.
It is expected about 20 people will participate in this research study.
The National Institutes of Health is supporting this research study by providing study funds.
The Masssachusetts Institute of Technology (MIT) is supporting this research by providing the nonlinear microscope.
- Conditions
- Prostate Cancer
- Being tested
- Nonlinear Microscope (NLM)
- Keywords
- Prostate Cancer, Intraoperative imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonlinear Microscope (NLM)Device
The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.
| Study group | Role | What they receive |
|---|---|---|
| Nonlinear Microscopy | Experimental | Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy) Receives: Device: Nonlinear Microscope (NLM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Success Rate
Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.
Measured: From screening through informed consent completion (up to Day 0 or baseline visit).
Retention Success Rate
Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period.
Measured: Up to 30 days post-surgery.
Technical and Workflow Feasibility Rate
Feasibility rate is defined as the proportion of enrolled participants undergoing robot-assisted radical prostatectomy for whom intraoperative NLM-based specimen margin evaluation meets all predefined feasibility criteria, including timely actionable pathologic feedback, effective real-time communication, and the ability to perform secondary NVB resection when indicated.
Measured: On the day of robot-assisted radical prostatectomy (Day 0)
Secondary outcomes (1)
Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment
Surgical margins will be classified as positive or negative by both intraoperative NLM and postoperative FFPE H\&E, with FFPE H\&E serving as the reference standard. The unit of analysis for concordance will be per side, aligning with the unit of surgical action. Concordance will be evaluated by comparing margin status determinations across corresponding margin locations. Separate concordance estimates will be calculated for initial nerve-sparing excision specimens (typically 1-2 per participant) and for neurovascular bundle secondary resections, which are relatively rare and are expected in approximately 1-2 per 20 participants.
Measured: Up to 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startJun 2026 (estimated)
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Peter Chang, Beth Israel Deaconess Medical Center
- Investigators
- Peter Chang, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516808
- Sponsor's protocol ID
- 25-735
- Other IDs
- R01CA249151
- Status last verified
- Feb 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy
- ClinicalTrials.gov ID
- NCT07516808
- Acronym / sponsor ID
- 25-735
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Intraoperative imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Massachusetts Institute of Technology
- Study start
- Jun 2026 (estimated)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Aug 2027 (estimated)
- First posted
- 8 Apr 2026 (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 will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.
Detailed description
This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind.
The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses.
The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery.
It is expected about 20 people will participate in this research study.
The National Institutes of Health is supporting this research study by providing study funds.
The Masssachusetts Institute of Technology (MIT) is supporting this research by providing the nonlinear microscope.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonlinear Microscopy | Experimental | Device: Nonlinear Microscope (NLM)Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Male or assigned male at birth (AMAB).
- Initial diagnosis of localized PrCa.
- Undergoing radical prostatectomy at BIDMC as part of their standard of care.
Key exclusion criteria (4 listed)
- No short-form available in the participant's language.
- Cognitively unable to provide consent, in the opinion of the investigator.
- Patients with evidence of unequivocal radiologic bilateral extraprostatic extension (EPE) on most recent MRI results.
- Patients with >80 cc prostate volume (larger prostates would require potentially excessive evaluation time).
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 |
|---|---|---|
| Nonlinear Microscope (NLM)The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins. | Device | Nonlinear Microscopy |
Primary outcome
Enrollment Success Rate
Time frame: From screening through informed consent completion (up to Day 0 or baseline visit).
Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.
Retention Success Rate
Time frame: Up to 30 days post-surgery.
Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period.
Technical and Workflow Feasibility Rate
Time frame: On the day of robot-assisted radical prostatectomy (Day 0)
Feasibility rate is defined as the proportion of enrolled participants undergoing robot-assisted radical prostatectomy for whom intraoperative NLM-based specimen margin evaluation meets all predefined feasibility criteria, including timely actionable pathologic feedback, effective real-time communication, and the ability to perform secondary NVB resection when indicated.
1 secondary outcome
Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment
Time frame: Up to 30 days post-surgery.
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 8 Apr 2026.
- Individual participant dataSharing planned: Yes. The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Peter Chang, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonlinear Microscope (NLM) in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Apr 2026. 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 Peter Chang, MD (617-667-3739, pchang@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Success Rate (time frame: From screening through informed consent completion (up to Day 0 or baseline visit).). The study lists 3 primary outcomes in all. 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 8 Apr 2026.