Prostate CancerAURORANCT05960669
Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
A study testing 3D model guided secondary resection in people with Prostate Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 3D model guided secondary resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 26 Aug 2022
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preoperatively planed and intraoperatively performed nerve-sparing approach (at least unilateral)
- suitable pelvic MRI for the creation of a personalized 3D prostate model,
- written patient consent
Who cannot join
- no nerve sparing performed
Trial locations and contacts
1 site in 1 country.
About this study
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Read the detailed description
Background:
Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR).
Objective:
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Design, setting and participants:
100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study.
Interventions:
A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR.
Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.
- Conditions
- Prostate Cancer
- Being tested
- 3D model guided secondary resection
- Keywords
- prostatectomy, nerve sparing, 3D model, urology, frozen section
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D model guided secondary resectionProcedure or surgery
A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.
| Study group | Role | What they receive |
|---|---|---|
| 3D model guided SR | Experimental | A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection. Receives: Procedure: 3D model guided secondary resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status
Measured: 4 weeks
Secondary outcomes (2)
Erectile function
IIEF-5
Measured: 1 year
Oncologic follow-up
PSA Monitoring
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2018
- Primary completion26 Aug 2021
- Study completion26 Aug 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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort Study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Christian CE Engesser, Dr., Principal investigator, University Hospital, Basel, SwitzerlandJan JE Ebbing, PD Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960669
- Sponsor's protocol ID
- AURORA_2018
- Acronym
- AURORA
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
- ClinicalTrials.gov ID
- NCT05960669
- Acronym / sponsor ID
- AURORA / AURORA_2018
- Conditions
- Prostate Cancer
- Keywords
- prostatectomy, nerve sparing, 3D model, urology, frozen section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 27 Jul 2023 (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.
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Detailed description
Background:
Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR).
Objective:
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Design, setting and participants:
100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study.
Interventions:
A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR.
Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort Study
| Arm | Type | Receives |
|---|---|---|
| 3D model guided SR | Experimental | Procedure: 3D model guided secondary resectionA prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- preoperatively planed and intraoperatively performed nerve-sparing approach (at least unilateral)
- suitable pelvic MRI for the creation of a personalized 3D prostate model,
- written patient consent
Key exclusion criteria (1 listed)
- no nerve sparing performed
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 |
|---|---|---|
| 3D model guided secondary resectionA prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection. | Procedure or surgery | 3D model guided SR |
Primary outcome
comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status
Time frame: 4 weeks
2 secondary outcomes
Erectile function
Time frame: 1 year
Oncologic follow-up
Time frame: 1 year
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 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingEarly Phase 1
FTT PET/CT in Metastatic Prostate Cancer
Prostate Cancer Metastatic
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingPhase 2
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Recurrent Prostate Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
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.
Christian CE Engesser, Dr. principal investigator
University Hospital, Basel, Switzerland
Jan JE Ebbing, PD Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D model guided secondary resection in people with Prostate Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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 19 Oct 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 Switzerland. 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?
comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status (time frame: 4 weeks). 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 19 Oct 2026.