Robotic-Assisted Radical ProstatectomyNCT06977906
Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes
A study testing conventional Robotic-assisted radical prostatectomy group and Improved Robotic-assisted radical prostatectomy group in people with Robotic-Assisted Radical Prostatectomy and Locally Advanced Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This study is a prospective, single-center clinical trial. It aims to establish an improved robotic-assisted radical prostatectomy for treating locally advanced prostate cancer. The technique evaluates the impact of preserving the anterior peritoneum of the bladder on postoperative bladder descent and urinary control… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension
- What is being tested?
- conventional Robotic-assisted radical prostatectomy group and Improved Robotic-assisted radical prostatectomy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate biopsy and clinical confirmation of high-risk prostate cancer (PSA > 20 ng/mL, Gleason score ≥ 8, or cT stage ≥ T2c) followed by robotic-assisted radical prostatectomy
- multiparametric MRI (mpMRI) with a 3.0 T scanner for prostate or pelvic scans performed within 30 days before the operation at our center
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1
- Complete clinical and prostate biopsy pathological data.
- General health is good, with no infections, autoimmune diseases, hematologic disorders, or other malignancies.
Who cannot join
- Presence of surgical contraindications.
- refusal of enhanced mpMRI imaging.
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, 1 recruiting
- Recruiting
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, 350005
Xu Ning, +8613235907575, drxun@fjmu.edu.cn
Ning
About this study
This study is a prospective, single-center clinical trial. It aims to establish an improved robotic-assisted radical prostatectomy for treating locally advanced prostate cancer. The technique evaluates the impact of preserving the anterior peritoneum of the bladder on postoperative bladder descent and urinary control recovery. A retrospective analysis compares this modified approach with traditional anterior approach surgery, assessing differences in oncological outcomes, early functional recovery, and postoperative complication rates. The goal is to provide new theoretical foundations and technical support for the prevention and treatment of postoperative urinary incontinence.
- Conditions
- Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension
- Being tested
- conventional Robotic-assisted radical prostatectomy group, Improved Robotic-assisted radical prostatectomy group
- Keywords
- Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional Robotic-assisted radical prostatectomy groupProcedure or surgery
Robotic-assisted radical prostatectomy uses a standard anterior approach with transabdominal or extraperitoneal access. After establishing pneumoperitoneum, the Retzius space is dissected to expose the prostate. The deep dorsal venous complex is ligated to control bleeding, and the bladder neck is carefully dissected while preserving the ureters. Seminal vesicles, vas deferens, and neurovascular bundles are selectively preserved based on tumor characteristics. A tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is done if necessary. The robotic system ensures precise dissection, hemostasis, and suturing, optimizing oncological control while preserving urinary continence and sexual function with reduced bleeding and complications.
Improved Robotic-assisted radical prostatectomy groupProcedure or surgery
The procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement.
| Study group | Role | What they receive |
|---|---|---|
| conventional Robotic Assisted Radical Prostatectomy group | Active comparator | The conventional RARP utilizes a traditional anterior approach through the patient's head-down, feet-up supine position, with either transabdominal or extraperitoneal access. After establishing pneumoperitoneum, precise dissection of the Retzius space is performed to expose the prostate and surrounding structures. The deep dorsal venous complex is pre-emptively ligated to control bleeding, followed by sharp dissection of the bladder neck while preserving the ureteral orifices. The seminal vesicles and vas deferens are then mobilized, with selective preservation of the neurovascular bundles based on the tumor's characteristics to maintain erectile function. The prostate apex and urethra are delicately dissected while protecting the sphincter, and after complete prostate removal, a continuous, tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is carried out if necessary. Throughout the procedure Receives: Procedure: Improved Robotic-assisted radical prostatectomy group |
| Improved Robotic-Assisted Radical Prostatectomy group | Experimental | The procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement. Receives: Procedure: conventional Robotic-assisted radical prostatectomy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of continence
Time Frame:1 week, 1 month and 3 month after postoperative removal of the urinary catheter
Measured: 1 week, 1 month and 3 month after postoperative removal of the urinary catheter
The degree of bladder descent
Time Frame:1 month after operation
Measured: 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic-Assisted Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977906
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2025]546
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes
- ClinicalTrials.gov ID
- NCT06977906
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2025]546
- Conditions
- Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension
- Keywords
- Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 May 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.
This study is a prospective, single-center clinical trial. It aims to establish an improved robotic-assisted radical prostatectomy for treating locally advanced prostate cancer. The technique evaluates the impact of preserving the anterior peritoneum of the bladder on postoperative bladder descent and urinary control recovery. A retrospective analysis compares this modified approach with traditional anterior approach surgery, assessing differences in oncological outcomes, early functional recovery, and postoperative complication rates. The goal is to provide new theoretical foundations and technical support for the prevention and treatment of postoperative urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional Robotic Assisted Radical Prostatectomy group | Active comparator | Procedure: Improved Robotic-assisted radical prostatectomy groupThe conventional RARP utilizes a traditional anterior approach through the patient's head-down, feet-up supine position, with either transabdominal or extraperitoneal access. After establishing pneumoperitoneum, precise dissection of the Retzius space is performed to expose the prostate and surrounding structures. The deep dorsal venous complex is pre-emptively ligated to control bleeding, followed by sharp dissection of the bladder neck while preserving the ureteral orifices. The seminal vesicles and vas deferens are then mobilized, with selective preservation of the neurovascular bundles based on the tumor's characteristics to maintain erectile function. The prostate apex and urethra are delicately dissected while protecting the sphincter, and after complete prostate removal, a continuous, tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is carried out if necessary. Throughout the procedure |
| Improved Robotic-Assisted Radical Prostatectomy group | Experimental | Procedure: conventional Robotic-assisted radical prostatectomy groupThe procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- prostate biopsy and clinical confirmation of high-risk prostate cancer (PSA > 20 ng/mL, Gleason score ≥ 8, or cT stage ≥ T2c) followed by robotic-assisted radical prostatectomy
- multiparametric MRI (mpMRI) with a 3.0 T scanner for prostate or pelvic scans performed within 30 days before the operation at our center
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1
- Complete clinical and prostate biopsy pathological data.
- General health is good, with no infections, autoimmune diseases, hematologic disorders, or other malignancies.
Key exclusion criteria (2 listed)
- Presence of surgical contraindications.
- refusal of enhanced mpMRI imaging.
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 |
|---|---|---|
| conventional Robotic-assisted radical prostatectomy groupRobotic-assisted radical prostatectomy uses a standard anterior approach with transabdominal or extraperitoneal access. After establishing pneumoperitoneum, the Retzius space is dissected to expose the prostate. The deep dorsal venous complex is ligated to control bleeding, and the bladder neck is carefully dissected while preserving the ureters. Seminal vesicles, vas deferens, and neurovascular bundles are selectively preserved based on tumor characteristics. A tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is done if necessary. The robotic system ensures precise dissection, hemostasis, and suturing, optimizing oncological control while preserving urinary continence and sexual function with reduced bleeding and complications. | Procedure or surgery | Improved Robotic-Assisted Radical Prostatectomy group |
| Improved Robotic-assisted radical prostatectomy groupThe procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement. | Procedure or surgery | conventional Robotic Assisted Radical Prostatectomy group |
Primary outcome
rate of continence
Time frame: 1 week, 1 month and 3 month after postoperative removal of the urinary catheter
Time Frame:1 week, 1 month and 3 month after postoperative removal of the urinary catheter
The degree of bladder descent
Time frame: 1 month after operation
Time Frame:1 month after operation
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 18 May 2025.
- Individual participant dataSharing planned: Undecided
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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 conventional Robotic-assisted radical prostatectomy group and Improved Robotic-assisted radical prostatectomy group in people with Robotic-Assisted Radical Prostatectomy and Locally Advanced Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University 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 5 inclusion and 2 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 18 May 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 Xu Ning, Dr. (+8613235907575, drxun@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of continence (time frame: 1 week, 1 month and 3 month after postoperative removal of the urinary catheter). The study lists 2 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 18 May 2025.