Prostate CancerNCT07272317
PSMA-PET/MRI-Ultrasound Multimodal Fusion Navigation for Da Vinci Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial
A study testing experimental group (navigation-assisted RARP) in people with Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Radical prostatectomy faces the core dilemma of balancing functional preservation with tumor eradication. While nerve-sparing techniques improve urinary control, intraoperative tumor localization remains imprecise, resulting in positive surgical margin (PSM) rates of 11%-38% and elevated recurrence risk. Read more about this study
- Who is it for?
- Ages Up to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- experimental group (navigation-assisted RARP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 30 Dec 2026
- 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 Up to 90 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Target Population: Patients with clinical stage T3a, or T2 (with the lesion close to the surface of the prostate) scheduled for robot-assisted radical prostatectomy (RARP), who have been diagnosed with prostate cancer.
- Age 50 - 80 years old;
- Pathologically confirmed as prostate adenocarcinoma (Gleason score 6 - 10);
- PSMA-PET/MRI indicates extracapsular invasion of the lesion; ④ Signed informed consent and committed to completing follow-up.
Who cannot join
- ① Metastasis (M1 stage) or lymph node metastasis (N1 stage);
- Previous pelvic radiotherapy or endocrine therapy history;
- Severe cardiopulmonary dysfunction (ASA grade ≥ III); ④ Mental illness or cognitive impairment that cannot cooperate with assessment; ⑤ Participating in other interventional clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Jing Zhao, Doctor, +8618101917512, jane_zhaoj@163.com
About this study
Radical prostatectomy faces the core dilemma of balancing functional preservation with tumor eradication. While nerve-sparing techniques improve urinary control, intraoperative tumor localization remains imprecise, resulting in positive surgical margin (PSM) rates of 11%-38% and elevated recurrence risk. Traditional preoperative 2D imaging fails to dynamically guide surgical boundaries. Although multimodal fusion studies (e.g., MRI or PSMA-PET/CT) attempt to address this, they struggle to achieve simultaneous precision in lesion identification and real-time spatial tracking. This study pioneers a PSMA-PET/MRI-ultrasound multimodal fusion navigation system for the Da Vinci surgical robot, leveraging three innovations: PSMA-PET/MRI dual-modality synergy for subclinical lesion detection at millimeter resolution; Non-rigid point-cloud registration algorithms to dynamically compensate for intraoperative prostate deformation, enabling 3D ultrasound-PET/MRI elastic fusion; Utilizing the telipro port of the Da Vinci surgical robot to achieve intraoperative picture-in-picture navigation, real-time localization of the tumor boundary, and precise resection as well as precise protection.This study aims to verify the safety and effectiveness of the world's first PSMA-PET/MRI-ultrasound multimodal fusion navigation system adapted for the Da Vinci surgical robot. This system is expected to reduce the positive margin rate to less than 10%, increase the rate of nerve preservation by 30%, shorten the postoperative urinary control recovery time to within 2 weeks, and establish a standard process for robotic surgery navigation. This will provide a new paradigm for precise surgical treatment of prostate cancer.
Read the detailed description
Prostate cancer, the second most prevalent malignancy in men globally, has long grappled with a core dilemma in radical surgery: balancing functional preservation against oncological efficacy. Although nerve-sparing techniques significantly improve postoperative urinary control and sexual function (with robotic surgery achieving >80% continence recovery rates), conventional approaches relying on intraoperative visual tumor boundary assessment result in positive surgical margin (PSM) rates of 11%- 38%, increasing biochemical recurrence risk exceeding 40% [1,2]. For locally advanced cases, sacrificing functional structures to ensure oncological radicality leads to postoperative erectile dysfunction rates up to 95% and urinary incontinence exceeding 50% [3].The essence of this conflict lies in: Extended resection reduces PSM rates but damages neurovascular bundles (NVBs) governing micturition and erectile function; Limited resection preserves function yet increases PSM risk due to residual microlesions-particularly in anatomically complex zones like the prostatic apex and anterior wall, where visual localization errors typically exceed 3 mm.
Preoperative imaging limitations exacerbate this: MRI offers high anatomical resolution (0.5 mm³) but cannot track intraoperative organ deformation; PSMA-PET/CT detects micrometastases with 98% sensitivity, yet spatial registration errors between metabolic/anatomical data exceed 2 mm [4]. Current multimodal fusion approaches are inadequate: MRI-based fusion misses early-stage lesions due to limited tumor contrast; PSMA-PET/CT fusion suffers from metabolic-anatomical misalignment.
Thus, a navigation system enabling simultaneous subclinical lesion detection and dynamic deformation compensation is imperative to resolve the function-versus-curability dilemma.
We have adopted the following approaches to complete the construction of the intraoperative navigation system: (1) On the PET/MRI before the operation, the prostate and the lesion were delineated: at least two nuclear medicine physicians independently reviewed the images and then provided a unified report; the external contour of the prostate and the three-dimensional lesion schematic diagram of the lesion were then delineated by a urologist; (2) On the intraoperative ultrasound, the prostate was delineated: the prostate image was captured in real time by BK ultrasound and then the external contour of the prostate was delineated by a urologist; (3) The multimodal fusion of the three-dimensional lesion delineated by BK ultrasound and PSMAPET/MRI was achieved through the MIM software built into the BK ultrasound; (4) The intraoperative resection was guided by the Da Vinci Tilepro functional module. So far, 6 cases have been successfully completed and compared with 6 T3a patients randomly selected from previous conventional surgeries. Currently, due to the small sample size, although the differences in the surgical margins have not reached a statistically significant difference, a trend of difference has been demonstrated. Due to the short follow-up period, the postoperative PSA and urination conditionshave not been included in the statistical cohort.
- Conditions
- Prostate Cancer
- Being tested
- experimental group (navigation-assisted RARP)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental group (navigation-assisted RARP)Procedure or surgery
Before the surgery, the prostate and lesions were delineated on PET/MRI: at least two nuclear medicine physicians independently reviewed the images and provided a unified report. The experimental group had the external contour of the prostate and the three-dimensional lesion schematic diagram delineated by the urologist. A BK5000 ultrasound probe was inserted into the rectum, the probe was fixed to the surgical bed frame by the stepper, and the real-time images of the prostate were captured by the ultrasound.The multimodal fusion of the three-dimensional lesion outlined by ultrasound and PSMA-PET/MRI was achieved through the built-in MIM software. Subsequently, picture-in-picture guidance was realized through the Da Vinci Tilepro functional module, and the edge of the lesion was marked with titanium clips. After the ultrasound probe was withdrawn, the peripheral resection of the prostate, nerve preserve or not were completed under the guidance of the titanium clips.
| Study group | Role | What they receive |
|---|---|---|
| experimental group（navigation-assisted RARP） | Experimental | The experimental group will use preoperative PSMA-PET/MRI and intraoperative ultrasound for multimodal fusion to construct a three-dimensional model and synchronize it in real time to the surgeon's control console through the Da Vinci surgical robot's Tilepro video integration module, and complete the anterior approach laparoscopic radical prostatectomy under this guidance. Receives: Procedure: experimental group (navigation-assisted RARP) |
| Control group (traditional RARP) | No intervention | The control group will undergo the anterior approach laparoscopic radical prostatectomy in the conventional manner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive margin rate
Positive margin rate (prostate radical specimens need to be stained with standard ink, and the contact between tumor cells and the ink surface of the surgical specimen is considered a positive margin; two pathologists with qualifications of associate chief physician or above (who need to have 5 years of prostate pathology diagnosis experience) blind to the patient information and independently read the films， if the two interpretations are inconsistent，the third senior pathologist (senior professional title) will review) .
Measured: After being enrolled, the patient undergoes radical prostatectomy for prostate cancer. Around 7 to 10 days after the surgery, the pathological report will be available.
Secondary outcomes (5)
Nerve Preservation Success Rate, as assessed by International Index of Erectile Function-5 (IIEF-5) score and maximum urine flow rate (Qmax)
The proportion of patients achieving nerve preservation success, defined as simultaneouslyhaving an International Index of Erectile Function-5 (IIEF-5) score ≥ 21 and a maximum urine flow rate (Qmax) ≥ 15 ml/s at 6 months after surgery
Measured: Follow-up was conducted for 6 months after the surgery.
Time to Urinary Continence Recovery
The number of consecutive days from the date of surgery until the patient uses no more than one safety pad per day.
Measured: Follow-up was conducted for 6 months after the surgery.
Serum Prostate-Specific Antigen (PSA) Level
Extract the peripheral blood of patients, measure and record the PSA level (ng/ml) at 6 weeks, 3 months, and 6 months after surgery.
Measured: Follow-up was conducted for 6 months after the surgery.
Biochemical Recurrence Rate as assessed by PSA level after the surgery
The proportion of patients with biochemical recurrence after surgery, defined as a rising PSA level (e.g., PSA ≥ 0.2 ng/mL) confirmed by a second consecutive test.
Measured: Follow-up was conducted for 6 months after the surgery.
Number of participants with postoperative complications as assessed by the Clavien-Dindo classification system
Number of participants with postoperative complications according to the Clavien-Dindo classification system.
Measured: Follow-up was conducted for 6 months after the surgery.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-center, prospective randomized controlled trial. The research subjects are patients with T3a or T2 (with the lesion close to the surface of the prostate) prostate cancer who underwent robot-assisted radical prostatectomy (RARP) in our hospital. The subjects were randomly divided into a control group and an experimental group. Patients in the control group received RARP according to the conventional method, while patients in the experimental group underwent preoperative PSMA-PET/MRI-ultrasound multimodal fusion and RARP under real-time navigation assistance during the operation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Cheng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272317
- Sponsor's protocol ID
- 【2025】177
- Other IDs
- Y2025082
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sivarajan G, Prabhu V, Taksler GB, Laze J, Lepor H. Ten-year outcomes of sexual function after radical prostatectomy: results of a prospective longitudinal study. Eur Urol. 2014 Jan;65(1):58-65. doi: 10.1016/j.eururo.2013.08.019. Epub 2013 Aug 26.
PubMed 24007711Bakht MK, Beltran H. Biological determinants of PSMA expression, regulation and heterogeneity in prostate cancer. Nat Rev Urol. 2025 Jan;22(1):26-45. doi: 10.1038/s41585-024-00900-z. Epub 2024 Jul 8.
PubMed 38977769Zhang L, Wu B, Zha Z, Zhao H, Jiang Y, Yuan J. Positive surgical margin is associated with biochemical recurrence risk following radical prostatectomy: a meta-analysis from high-quality retrospective cohort studies. World J Surg Oncol. 2018 Jul 3;16(1):124. doi: 10.1186/s12957-018-1433-3.
PubMed 29970100Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol. 2012 Jul;62(1):1-15. doi: 10.1016/j.eururo.2012.02.029. Epub 2012 Feb 24.
PubMed 22405509
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET/MRI-Ultrasound Multimodal Fusion Navigation for Da Vinci Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07272317
- Acronym / sponsor ID
- 【2025】177
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Dec 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.
Radical prostatectomy faces the core dilemma of balancing functional preservation with tumor eradication. While nerve-sparing techniques improve urinary control, intraoperative tumor localization remains imprecise, resulting in positive surgical margin (PSM) rates of 11%-38% and elevated recurrence risk. Traditional preoperative 2D imaging fails to dynamically guide surgical boundaries. Although multimodal fusion studies (e.g., MRI or PSMA-PET/CT) attempt to address this, they struggle to achieve simultaneous precision in lesion identification and real-time spatial tracking. This study pioneers a PSMA-PET/MRI-ultrasound multimodal fusion navigation system for the Da Vinci surgical robot, leveraging three innovations: PSMA-PET/MRI dual-modality synergy for subclinical lesion detection at millimeter resolution; Non-rigid point-cloud registration algorithms to dynamically compensate for intraoperative prostate deformation, enabling 3D ultrasound-PET/MRI elastic fusion; Utilizing the telipro port of the Da Vinci surgical robot to achieve intraoperative picture-in-picture navigation, real-time localization of the tumor boundary, and precise resection as well as precise protection.This study aims to verify the safety and effectiveness of the world's first PSMA-PET/MRI-ultrasound multimodal fusion navigation system adapted for the Da Vinci surgical robot. This system is expected to reduce the positive margin rate to less than 10%, increase the rate of nerve preservation by 30%, shorten the postoperative urinary control recovery time to within 2 weeks, and establish a standard process for robotic surgery navigation. This will provide a new paradigm for precise surgical treatment of prostate cancer.
Detailed description
Prostate cancer, the second most prevalent malignancy in men globally, has long grappled with a core dilemma in radical surgery: balancing functional preservation against oncological efficacy. Although nerve-sparing techniques significantly improve postoperative urinary control and sexual function (with robotic surgery achieving >80% continence recovery rates), conventional approaches relying on intraoperative visual tumor boundary assessment result in positive surgical margin (PSM) rates of 11%- 38%, increasing biochemical recurrence risk exceeding 40% [1,2]. For locally advanced cases, sacrificing functional structures to ensure oncological radicality leads to postoperative erectile dysfunction rates up to 95% and urinary incontinence exceeding 50% [3].The essence of this conflict lies in: Extended resection reduces PSM rates but damages neurovascular bundles (NVBs) governing micturition and erectile function; Limited resection preserves function yet increases PSM risk due to residual microlesions-particularly in anatomically complex zones like the prostatic apex and anterior wall, where visual localization errors typically exceed 3 mm.
Preoperative imaging limitations exacerbate this: MRI offers high anatomical resolution (0.5 mm³) but cannot track intraoperative organ deformation; PSMA-PET/CT detects micrometastases with 98% sensitivity, yet spatial registration errors between metabolic/anatomical data exceed 2 mm [4]. Current multimodal fusion approaches are inadequate: MRI-based fusion misses early-stage lesions due to limited tumor contrast; PSMA-PET/CT fusion suffers from metabolic-anatomical misalignment.
Thus, a navigation system enabling simultaneous subclinical lesion detection and dynamic deformation compensation is imperative to resolve the function-versus-curability dilemma.
We have adopted the following approaches to complete the construction of the intraoperative navigation system: (1) On the PET/MRI before the operation, the prostate and the lesion were delineated: at least two nuclear medicine physicians independently reviewed the images and then provided a unified report; the external contour of the prostate and the three-dimensional lesion schematic diagram of the lesion were then delineated by a urologist; (2) On the intraoperative ultrasound, the prostate was delineated: the prostate image was captured in real time by BK ultrasound and then the external contour of the prostate was delineated by a urologist; (3) The multimodal fusion of the three-dimensional lesion delineated by BK ultrasound and PSMAPET/MRI was achieved through the MIM software built into the BK ultrasound; (4) The intraoperative resection was guided by the Da Vinci Tilepro functional module. So far, 6 cases have been successfully completed and compared with 6 T3a patients randomly selected from previous conventional surgeries. Currently, due to the small sample size, although the differences in the surgical margins have not reached a statistically significant difference, a trend of difference has been demonstrated. Due to the short follow-up period, the postoperative PSA and urination conditionshave not been included in the statistical cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-center, prospective randomized controlled trial. The research subjects are patients with T3a or T2 (with the lesion close to the surface of the prostate) prostate cancer who underwent robot-assisted radical prostatectomy (RARP) in our hospital. The subjects were randomly divided into a control group and an experimental group. Patients in the control group received RARP according to the conventional method, while patients in the experimental group underwent preoperative PSMA-PET/MRI-ultrasound multimodal fusion and RARP under real-time navigation assistance during the operation.
| Arm | Type | Receives |
|---|---|---|
| experimental group（navigation-assisted RARP） | Experimental | Procedure: experimental group (navigation-assisted RARP)The experimental group will use preoperative PSMA-PET/MRI and intraoperative ultrasound for multimodal fusion to construct a three-dimensional model and synchronize it in real time to the surgeon's control console through the Da Vinci surgical robot's Tilepro video integration module, and complete the anterior approach laparoscopic radical prostatectomy under this guidance. |
| Control group (traditional RARP) | No intervention | –The control group will undergo the anterior approach laparoscopic radical prostatectomy in the conventional manner. |
Who may qualify
- Ages
- Up to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Target Population: Patients with clinical stage T3a, or T2 (with the lesion close to the surface of the prostate) scheduled for robot-assisted radical prostatectomy (RARP), who have been diagnosed with prostate cancer.
Key exclusion criteria (3 listed)
- ① Metastasis (M1 stage) or lymph node metastasis (N1 stage);
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 |
|---|---|---|
| experimental group (navigation-assisted RARP)Before the surgery, the prostate and lesions were delineated on PET/MRI: at least two nuclear medicine physicians independently reviewed the images and provided a unified report. The experimental group had the external contour of the prostate and the three-dimensional lesion schematic diagram delineated by the urologist. A BK5000 ultrasound probe was inserted into the rectum, the probe was fixed to the surgical bed frame by the stepper, and the real-time images of the prostate were captured by the ultrasound.The multimodal fusion of the three-dimensional lesion outlined by ultrasound and PSMA-PET/MRI was achieved through the built-in MIM software. Subsequently, picture-in-picture guidance was realized through the Da Vinci Tilepro functional module, and the edge of the lesion was marked with titanium clips. After the ultrasound probe was withdrawn, the peripheral resection of the prostate, nerve preserve or not were completed under the guidance of the titanium clips. | Procedure or surgery | experimental group（navigation-assisted RARP） |
Primary outcome
Positive margin rate
Time frame: After being enrolled, the patient undergoes radical prostatectomy for prostate cancer. Around 7 to 10 days after the surgery, the pathological report will be available.
Positive margin rate (prostate radical specimens need to be stained with standard ink, and the contact between tumor cells and the ink surface of the surgical specimen is considered a positive margin; two pathologists with qualifications of associate chief physician or above (who need to have 5 years of prostate pathology diagnosis experience) blind to the patient information and independently read the films， if the two interpretations are inconsistent，the third senior pathologist (senior professional title) will review) .
5 secondary outcomes
Nerve Preservation Success Rate, as assessed by International Index of Erectile Function-5 (IIEF-5) score and maximum urine flow rate (Qmax)
Time frame: Follow-up was conducted for 6 months after the surgery.
Time to Urinary Continence Recovery
Time frame: Follow-up was conducted for 6 months after the surgery.
Serum Prostate-Specific Antigen (PSA) Level
Time frame: Follow-up was conducted for 6 months after the surgery.
Biochemical Recurrence Rate as assessed by PSA level after the surgery
Time frame: Follow-up was conducted for 6 months after the surgery.
Number of participants with postoperative complications as assessed by the Clavien-Dindo classification system
Time frame: Follow-up was conducted for 6 months after the 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 9 Dec 2025.
- Background: PubMed 24007711Sivarajan G, Prabhu V, Taksler GB, Laze J, Lepor H. Ten-year outcomes of sexual function after radical prostatectomy: results of a prospective longitudinal study. Eur Urol. 2014 Jan;65(1):58-65. doi: 10.1016/j.eururo.2013.08.019. Epub 2013 Aug 26.
- Background: PubMed 38977769Bakht MK, Beltran H. Biological determinants of PSMA expression, regulation and heterogeneity in prostate cancer. Nat Rev Urol. 2025 Jan;22(1):26-45. doi: 10.1038/s41585-024-00900-z. Epub 2024 Jul 8.
- Background: PubMed 29970100Zhang L, Wu B, Zha Z, Zhao H, Jiang Y, Yuan J. Positive surgical margin is associated with biochemical recurrence risk following radical prostatectomy: a meta-analysis from high-quality retrospective cohort studies. World J Surg Oncol. 2018 Jul 3;16(1):124. doi: 10.1186/s12957-018-1433-3.
- Background: PubMed 22405509Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol. 2012 Jul;62(1):1-15. doi: 10.1016/j.eururo.2012.02.029. Epub 2012 Feb 24.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group (navigation-assisted RARP) in people with Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 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: opening soon, as of the sponsor's last update on 9 Dec 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 China. 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 Cheng Liu, Doctor (+8618663760823, chengliumd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive margin rate (time frame: After being enrolled, the patient undergoes radical prostatectomy for prostate cancer. Around 7 to 10 days after the surgery, the pathological report will be available.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272317, which also lists 4 linked publications.
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 Dec 2025.