Prostate Cancer (Adenocarcinoma)NICE-PSMANCT07129551
Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
A study testing preop virtual 3D model and postop 3D model in people with Prostate Cancer (Adenocarcinoma), run by Martini-Klinik am UKE GmbH at 2 sites in Germany.
Trial summary
As part of a feasibility study, it's planned to use a 3D virtual mixed reality model with prostate cancer patients who show signs of lymph node metastasis and are scheduled for surgery. Read more about this study
- Who is it for?
- Ages 18 to 78 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- preop virtual 3D model and postop 3D model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Jan 2026to Dec 2028
- 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 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort A:
- Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection
- <3 PSMA-PET-avid lymph node metastases (PSMA expression score >2) in the pelvis.
- Cohort B:
- Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection
- <3 PSMA-PET-avid lymph node metastases (PSMA expression score >2) in the pelvis
- PSA value <2ng/ml.
Who cannot join
- Estimated life expectancy <10 years
- contraindication for surgical intervention
- androgen deprivation therapy (ADT) within the last 3 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Martini-Klinik
Hamburg, Free and Hanseatic City of Hamburg, 20246
Tobias Maurer, Prof. Dr., +4940741053115, t.maurer@uke.de
- Not yet recruiting
Anke Renter
Hamburg, Free and Hanseatic City of Hamburg, 25479
Anke Renter, +4940741053115, a.renter@uke.de
About this study
As part of a feasibility study, it's planned to use a 3D virtual mixed reality model with prostate cancer patients who show signs of lymph node metastasis and are scheduled for surgery. The model is based on PSMA PET imaging performed prior to surgery and will be evaluated by surgeons, the surgical team, and patients as part of the consultation process. First, the researcher investigates whether the removal of lymph node metastases has improved compared to the data in the literature . In addition, the study examines how the 3D model influences the movement of surgical instruments and the efficiency of surgical removal of lymph node metastases. To this end, the analyzed recorded video and position data of the instruments used during procedures performed with a surgical robot. It's also an aim to develop two methods-using landmarks and visual position tracking-for more targeted navigation during surgery. Additionally, short-term results examine, such as PSA response rates, as an indication of successful lymph node metastasis removal and patient quality of life.
Read the detailed description
In this prospective feasibility study, it's planned to use a 3D virtual mixed reality model based on the preoperative PSMA PET. The model will be evaluated as an educational tool for patients and surgeons in cases of primary high-risk prostate cancer and prostate cancer recurrence with PSMA PET-positive lymph node metastasis. In general, the detection rate of PSMA-guided surgical procedures will investigate with the histological result as the reference. Furthermore, the influence of 3D visualization on the movement of surgical instruments and the efficiency of targeted resection is analyzed the help of image data from two cameras and the position data of the instruments during robot-assisted procedures. Additionally, will the investigators develop and examine two navigation methods (landmark-based registration and visual tracking) in a retrospective approach that use the preoperative PSMA PET and the image and instrument position data captured during robotic procedures. The short-term oncological outcomes (PSA response rates) will examine as an indicator of the successful removal of macroscopic PSMA-PET-positive lesions and the quality of life (QoL) of patients.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- preop virtual 3D model, postop 3D model
- Keywords
- PSMA, targeted surgery, radioguided surgery, 3D model navigation
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preop virtual 3D modelProcedure or surgery
Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively
postop 3D modelProcedure or surgery
Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| preop virtual 3D model | Experimental | Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively Receives: Procedure: preop virtual 3D model |
| Control Intervention | Active comparator | Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated Receives: Procedure: postop 3D model |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan).
The 3D model is used for surgical guidance during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B). The postoperative histology of the specifically dissected tissue serves as a reference.
Measured: two weeks post surgery
Secondary outcomes (5)
Feasibility and accuracy of preoperative virtual 3D modeling for patient consultation and surgical planning (determined by pre- and postoperative standardized User Experience Questionnaire (UEQ) and Mixed reality Questionnaire).
Here, UEQ and Mixed realty Questionaires are evaluated. Here, no comparisons are made between randomized groups as the questionaires are only answered after presentation of the model. This endpoint is only evaluated in a descriptive manner reporting the values of each question within the questionaires (on a scale from 1-7 for the UEQ and 1-5 for the Mixed reality Questionaire)
Measured: six months after surgery
Retrospective analysis of vision-based and robotic tracking methods for target detection and retrospective analysis of the efficiency of PSMA-targeted dissection based on instrument tracking information (in robotic surgery)
Here, only for robotic procedures intraoperative tracking of the instruments will be recorded via the simultaneous recording of the two camera lenses of the robotic camera system as well as by the provided access of instrument movements. The recordings as well as the movement towards the PSMA PET positive lesion intraoperatively will be evaluated in the whole population and, if feasible, also for the patient cohorts with or without prior 3D model visualization
Measured: six months after surgery
Diagnostic accuracy of PSMA-PET-CT for detection of lymph node metastases during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B)
Here, as secondary outcome measurement the findings of properative PSMA-PET/CT will be compared with post-operative histology on a patient-side basis and at region-level (external iliac, obturator, internal iliac, common iliac, other locations) providing then results for true positive, false positive, true negative and false negative evaluations
Measured: six months after surgery
Short-term oncologic outcomes (complete biochemical response (cBR), defined as a PSA level <0.2 ng/mL at 8-12 weeks (Cohort A) or 4-6 weeks (Cohort B)).
Here, percentages (0-100%) of complete biochemical response at the predefined timepoints will be evaluated in between both cohorts, comparing the randomized groups
Measured: three months after surgery
Quality of life (SF-12, EPIC-26), morbidity (intra- and postoperative complications within 6 months according to the Clavien-Dindo classification) and satisfaction (Decision Regret Scale) after surgery
Here, standardized questionaires (SF-12, EPIC-26; mostly 5-scale evaluations) will be evaluated. Morbidity will be recorded according to Clavien-Dindo (CTC 1-5). Decision regret is evaluated according to the DRS (5-scale evaluations). Here, first the whole cohorts will be reported and then comparisons within the randomized groups in cohort A and B are made.
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start21 Jan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anke Renter, Martini-Klinik am UKE GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129551
- Sponsor's protocol ID
- 2024-PS-02
- Acronym
- NICE-PSMA
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery
- ClinicalTrials.gov ID
- NCT07129551
- Acronym / sponsor ID
- NICE-PSMA / 2024-PS-02
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- PSMA, targeted surgery, radioguided surgery, 3D model navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Study start
- 21 Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 2025 (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.
As part of a feasibility study, it's planned to use a 3D virtual mixed reality model with prostate cancer patients who show signs of lymph node metastasis and are scheduled for surgery. The model is based on PSMA PET imaging performed prior to surgery and will be evaluated by surgeons, the surgical team, and patients as part of the consultation process. First, the researcher investigates whether the removal of lymph node metastases has improved compared to the data in the literature . In addition, the study examines how the 3D model influences the movement of surgical instruments and the efficiency of surgical removal of lymph node metastases. To this end, the analyzed recorded video and position data of the instruments used during procedures performed with a surgical robot. It's also an aim to develop two methods-using landmarks and visual position tracking-for more targeted navigation during surgery. Additionally, short-term results examine, such as PSA response rates, as an indication of successful lymph node metastasis removal and patient quality of life.
Detailed description
In this prospective feasibility study, it's planned to use a 3D virtual mixed reality model based on the preoperative PSMA PET. The model will be evaluated as an educational tool for patients and surgeons in cases of primary high-risk prostate cancer and prostate cancer recurrence with PSMA PET-positive lymph node metastasis. In general, the detection rate of PSMA-guided surgical procedures will investigate with the histological result as the reference. Furthermore, the influence of 3D visualization on the movement of surgical instruments and the efficiency of targeted resection is analyzed the help of image data from two cameras and the position data of the instruments during robot-assisted procedures. Additionally, will the investigators develop and examine two navigation methods (landmark-based registration and visual tracking) in a retrospective approach that use the preoperative PSMA PET and the image and instrument position data captured during robotic procedures. The short-term oncological outcomes (PSA response rates) will examine as an indicator of the successful removal of macroscopic PSMA-PET-positive lesions and the quality of life (QoL) of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preop virtual 3D model | Experimental | Procedure: preop virtual 3D modelCohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively |
| Control Intervention | Active comparator | Procedure: postop 3D modelCohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection
- <3 PSMA-PET-avid lymph node metastases (PSMA expression score >2) in the pelvis.
- Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection
- <3 PSMA-PET-avid lymph node metastases (PSMA expression score >2) in the pelvis
- PSA value <2ng/ml.
Key exclusion criteria (3 listed)
- Estimated life expectancy <10 years
- contraindication for surgical intervention
- androgen deprivation therapy (ADT) within the last 3 months
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 |
|---|---|---|
| preop virtual 3D modelCohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively | Procedure or surgery | preop virtual 3D model |
| postop 3D modelCohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated | Procedure or surgery | Control Intervention |
Primary outcome
To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan).
Time frame: two weeks post surgery
The 3D model is used for surgical guidance during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B). The postoperative histology of the specifically dissected tissue serves as a reference.
5 secondary outcomes
Feasibility and accuracy of preoperative virtual 3D modeling for patient consultation and surgical planning (determined by pre- and postoperative standardized User Experience Questionnaire (UEQ) and Mixed reality Questionnaire).
Time frame: six months after surgery
Retrospective analysis of vision-based and robotic tracking methods for target detection and retrospective analysis of the efficiency of PSMA-targeted dissection based on instrument tracking information (in robotic surgery)
Time frame: six months after surgery
Diagnostic accuracy of PSMA-PET-CT for detection of lymph node metastases during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B)
Time frame: six months after surgery
Short-term oncologic outcomes (complete biochemical response (cBR), defined as a PSA level <0.2 ng/mL at 8-12 weeks (Cohort A) or 4-6 weeks (Cohort B)).
Time frame: three months after surgery
Quality of life (SF-12, EPIC-26), morbidity (intra- and postoperative complications within 6 months according to the Clavien-Dindo classification) and satisfaction (Decision Regret Scale) after surgery
Time frame: six months after 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 12 Jan 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preop virtual 3D model and postop 3D model in people with Prostate Cancer (Adenocarcinoma), run by Martini-Klinik am UKE GmbH at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Tobias Maurer, Professor (+4940741053115, t.maurer@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan). (time frame: two weeks post 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 12 Jan 2026.