Surgical Procedure, UnspecifiedNCT06434649
Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer
A study testing Extrafascial robotic assisted radical prostatectomy via posterior approach and Extrafascial robotic assisted radical prostatectomy via anterior approach in people with Surgical Procedure, Unspecified and Prostate Cancer, run by Ning Xu at 1 site in China.
Trial summary
This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Surgical Procedure, Unspecified, Prostate Cancer
- What is being tested?
- Extrafascial robotic assisted radical prostatectomy via posterior approach and Extrafascial robotic assisted radical prostatectomy via anterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;
- prostate volume <80 ml;
- life expectancy of patients >10 years;
- patients sign the "informed consent";
- Routine preoperative examination has been improved (chest CT, electrocardiogram, and color Doppler echocardiography), and there is no serious basic disease. After clinical evaluation, it can tolerance robot-assisted radical prostatectomy (RARP).
Who cannot join
- life expectancy <10 years;
- comorbidities with other malignancies;
- uncorrected coagulation dysfunctions;
- patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery;
- patients or family members who did not accept radical prostatectomy.
Trial locations and contacts
1 site in 1 country.
China1 site
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, 350005
About this study
Official title: Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients: a Prospective, Multicenter, Double-blind, Randomized Controlled Study
This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
Read the detailed description
This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
About 118 subjects will be enrolled in this study in a total of 12 research centres across the country, and eligible subjects will be randomly assigned to the posterior approach extrafascial technique group and the anterior approach extrafascial technique group in a 1:1 ratio. All subjects routinely underwent comprehensive and systematic physical examination, laboratory tests and imaging examinations before surgery. After surgery, subjects were followed up at 1 week (visit 2, day 14±2), 1 month (visit 3, day 28±5), 3 months (visit 4, day 90±7), 6 months (visit 5, day 180±7), and 12 months (visit 6, day 360±14) after removal of the urinary catheter after the surgery, and then annually thereafter (visit 7), with urine control rate (defined as 0/ 1 pad) and 24-h pad weight questionnaires, PSA examination, International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire Short Form (ICI-QSF), International Index of Erectile Function (IIEF), and related scores such as General Health-Related Quality of Life (EORTC QLQ-C30) and Prostate Cancer-Specific Quality of Life (QLQ-PR25). ) and other relevant scores; in case of clinical suspicion of local recurrence, imaging (pelvic MRI), whole-body bone imaging in patients with bone pain, and whole-body PET/CT if necessary. Subjects will be monitored and evaluated for adverse events (AE) throughout the trial. Subjects will participate in the clinical trial for an expected duration of approximately 1 year, after which they will be followed up periodically according to the usual follow-up strategy.
- Conditions
- Surgical Procedure, Unspecified, Prostate Cancer
- Being tested
- Extrafascial robotic assisted radical prostatectomy via posterior approach, Extrafascial robotic assisted radical prostatectomy via anterior approach
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extrafascial robotic assisted radical prostatectomy via posterior approachProcedure or surgery
Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.
Extrafascial robotic assisted radical prostatectomy via anterior approachProcedure or surgery
Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.
| Study group | Role | What they receive |
|---|---|---|
| the posterior approach extrafascial technique group | Experimental | In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP. Receives: Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approach |
| the anterior approach extrafascial technique group | Active comparator | Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy. Receives: Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of continence
rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
Measured: 1 week after postoperative removal of the urinary catheter
voiding score
according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint
Measured: through study completion, an average of 1 year
erectile function score
according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
the rate of positive specimen margins
the rate of positive specimen margins after surgery
Measured: after surgery, , an average of 1 year
quality of life scores
according to EORTC QLQ-C30, quality of life scores at each visit
Measured: through study completion, an average of 1 year
biochemical recurrence or imaging recurrence/progression
biochemical recurrence or imaging recurrence/progression at each visit
Measured: through study completion, an average of 1 year
overall survival time
deaths (overall survival time) at each visit
Measured: From date of randomization until date of death from any cause, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Nov 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Zhongshan Hospital Xiamen University, Fuzhou General Hospital, Longyan City First Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Ningbo No. 1 Hospital, Hainan People's Hospital, Second Affiliated Hospital of Third Military Medical University, First Affiliated Hospital of Zhejiang University, Huashan Hospital
- Responsible party
- Sponsor-investigator, Ning Xu, First Affiliated Hospital of Fujian Medical University
- Investigators
- Xue-Yi Xue, Study director, The First Affiliated Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434649
- Sponsor's protocol ID
- FirstAHFujian-Ning Xu
- Status last verified
- Nov 2025
- First submitted
- 10 May 2024
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients: a Prospective, Multicenter, Double-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06434649
- Acronym / sponsor ID
- FirstAHFujian-Ning Xu
- Conditions
- Surgical Procedure, Unspecified, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Ning XuUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Zhongshan Hospital Xiamen University, Fuzhou General Hospital, Longyan City First Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Ningbo No. 1 Hospital, Hainan People's Hospital, Second Affiliated Hospital of Third Military Medical University, First Affiliated Hospital of Zhejiang University, Huashan Hospital
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2024 (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 was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
Detailed description
This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
About 118 subjects will be enrolled in this study in a total of 12 research centres across the country, and eligible subjects will be randomly assigned to the posterior approach extrafascial technique group and the anterior approach extrafascial technique group in a 1:1 ratio. All subjects routinely underwent comprehensive and systematic physical examination, laboratory tests and imaging examinations before surgery. After surgery, subjects were followed up at 1 week (visit 2, day 14±2), 1 month (visit 3, day 28±5), 3 months (visit 4, day 90±7), 6 months (visit 5, day 180±7), and 12 months (visit 6, day 360±14) after removal of the urinary catheter after the surgery, and then annually thereafter (visit 7), with urine control rate (defined as 0/ 1 pad) and 24-h pad weight questionnaires, PSA examination, International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire Short Form (ICI-QSF), International Index of Erectile Function (IIEF), and related scores such as General Health-Related Quality of Life (EORTC QLQ-C30) and Prostate Cancer-Specific Quality of Life (QLQ-PR25). ) and other relevant scores; in case of clinical suspicion of local recurrence, imaging (pelvic MRI), whole-body bone imaging in patients with bone pain, and whole-body PET/CT if necessary. Subjects will be monitored and evaluated for adverse events (AE) throughout the trial. Subjects will participate in the clinical trial for an expected duration of approximately 1 year, after which they will be followed up periodically according to the usual follow-up strategy.
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 |
|---|---|---|
| the posterior approach extrafascial technique group | Experimental | Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approachIn 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP. |
| the anterior approach extrafascial technique group | Active comparator | Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approachAnterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;
- prostate volume <80 ml;
- life expectancy of patients >10 years;
- patients sign the "informed consent";
- Routine preoperative examination has been improved (chest CT, electrocardiogram, and color Doppler echocardiography), and there is no serious basic disease. After clinical evaluation, it can tolerance robot-assisted radical prostatectomy (RARP).
Key exclusion criteria (5 listed)
- life expectancy <10 years;
- comorbidities with other malignancies;
- uncorrected coagulation dysfunctions;
- patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery;
- patients or family members who did not accept radical prostatectomy.
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 |
|---|---|---|
| Extrafascial robotic assisted radical prostatectomy via posterior approachExtrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients. | Procedure or surgery | the posterior approach extrafascial technique group |
| Extrafascial robotic assisted radical prostatectomy via anterior approachExtrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients. | Procedure or surgery | the anterior approach extrafascial technique group |
Primary outcome
rate of continence
Time frame: 1 week after postoperative removal of the urinary catheter
rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
voiding score
Time frame: through study completion, an average of 1 year
according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint
erectile function score
Time frame: through study completion, an average of 1 year
according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint
4 secondary outcomes
the rate of positive specimen margins
Time frame: after surgery, , an average of 1 year
quality of life scores
Time frame: through study completion, an average of 1 year
biochemical recurrence or imaging recurrence/progression
Time frame: through study completion, an average of 1 year
overall survival time
Time frame: From date of randomization until date of death from any cause, an average of 5 year
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 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Surgical Procedure, Unspecified
Recruiting
Improving Surgical Communication for Patients in Wisconsin
Surgeons, Surgical Procedure, Unspecified
Active, not recruitingObservational study
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
Surgical Procedure, Unspecified, Intensive Care Units (ICUs)
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
Not yet recruitingPhase 4
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified
Recruiting
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Critical Illness, Surgical Procedure, Unspecified
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.
Xue-Yi Xue study director
The First Affiliated Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extrafascial robotic assisted radical prostatectomy via posterior approach and Extrafascial robotic assisted radical prostatectomy via anterior approach in people with Surgical Procedure, Unspecified and Prostate Cancer, run by Ning Xu 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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 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?
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?
rate of continence (time frame: 1 week after postoperative removal of the urinary catheter). The study lists 3 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 13 Apr 2026.