Prostate CancerNCT05317143
Evaluation of Prostate Cancer Margins
An observational study of Prostate Cancer, run by Intuitive Surgical at 1 site in Germany.
Trial summary
Pathological assessment of prostate tissue 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?
- Evaluation of prostate cancer margins
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2022to 10 Nov 2022
- Phase
- Observational
- 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
Study population: Patients with prostate cancer who undergo robotic-assisted prostatectomy
Who may be able to join
- Diagnosed with prostate cancer
- Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Pathological assessment of prostate tissue
- Conditions
- Prostate Cancer
- Being tested
- Evaluation of prostate cancer margins
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of prostate cancer marginsOther
Evaluation of prostate cancer margins
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Margin
Detection of positive margin
Measured: Immediately postoperatively, expected same day as surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start22 Feb 2022
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
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 Intuitive SurgicalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörn Hinrich Witt, PD Dr. med, Principal investigator, St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, GermanySami-Ramzi Leyh-Bannurah, PD Dr. med, Principal investigator, St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317143
- Sponsor's protocol ID
- 1091459C
- Status last verified
- Apr 2025
- First submitted
- 2 Feb 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prostate Cancer Margins
- ClinicalTrials.gov ID
- NCT05317143
- Acronym / sponsor ID
- 1091459C
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 7 Apr 2022 (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.
Pathological assessment of prostate tissue
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate cancer who undergo robotic-assisted prostatectomy
Key inclusion criteria (2 listed)
- Diagnosed with prostate cancer
- Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Evaluation of prostate cancer marginsEvaluation of prostate cancer margins | Other | – |
Primary outcome
Positive Margin
Time frame: Immediately postoperatively, expected same day as surgery
Detection of positive margin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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. This study is not recruiting at the moment.
Jörn Hinrich Witt, PD Dr. med principal investigator
St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
Sami-Ramzi Leyh-Bannurah, PD Dr. med principal investigator
St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Intuitive Surgical at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive Margin (time frame: Immediately postoperatively, expected same day as surgery). 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 9 Apr 2025.