Prostate CancerIAPREANCT07725653
Impact of Anterior Urethral Suspension Combined With Pelvic Fascia Reconstruction During Robot-Assisted Radical Prostatectomy on Early Postoperative Urinary Continence Recovery: A Single-Center, Prospective, Single-Arm Clinical Study
A study testing Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction in people with Prostate Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center prospective cohort study enrolling 60 to 100 patients with prostate cancer treated at The Cancer Hospital of the Chinese Academy of Medical Sciences between December 2025 and July 2026, who will receive modified RARP combined with anterior urethral suspension and pelvic fascia reconstruction. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 11 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Pathologically confirmed prostate cancer;
- 2. Scheduled to undergo modified robot-assisted radical prostatectomy;
- 3. Able to complete regular postoperative follow-up and functional assessment;
- 4. Voluntarily sign written informed consent.
Who cannot join
- 1. Previous history of pelvic radiotherapy or prostate surgery;
- 2. Severe cardiac, pulmonary, cerebrovascular, hepatic or renal dysfunction that cannot tolerate general anesthesia and surgery;
- 3. Neurogenic bladder or severe preoperative urinary incontinence;
- 4. Cognitive impairment making follow-up assessment impossible.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing
About this study
This is a single-center prospective cohort study enrolling 60 to 100 patients with prostate cancer treated at The Cancer Hospital of the Chinese Academy of Medical Sciences between December 2025 and July 2026, who will receive modified RARP combined with anterior urethral suspension and pelvic fascia reconstruction. The primary endpoint is the 3-month postoperative urinary continence recovery rate. Secondary endpoints include positive surgical margin rate, intraoperative blood loss, operative duration, postoperative complications, biochemical recurrence and other indicators. Standardized surgical procedures, standardized follow-up and multi-dimensional statistical analyses will be performed to clarify the functional benefits and oncological safety of this modified technique, so as to optimize surgical strategies for locally advanced prostate cancer.
Read the detailed description
This single-center prospective cohort study will enroll patients with localized and locally advanced prostate cancer at The Cancer Hospital of the Chinese Academy of Medical Sciences from December 2025 to July 2026. All participants will undergo modified robot-assisted radical prostatectomy combining anterior urethral suspension and pelvic fascia reconstruction. Eligible patients are aged 40-75 years with pathologically confirmed T2-T3 prostate cancer, candidates for robotic radical prostatectomy, complete clinical and imaging data, willingness to attend regular follow-up, and signed written informed consent. Exclusion criteria include prior pelvic radiotherapy or prostate surgery, severe organ dysfunction incompatible with general anesthesia, preoperative neurogenic bladder or persistent urinary incontinence, and refusal to complete the full follow-up schedule. All surgeries will be performed by the same senior urologist following standardized protocols. The core modified technique consists of anterior urethral suspension combined with pelvic fascia reconstruction to facilitate early postoperative urinary continence recovery; urinary continence is defined as using no more than one absorbent pad per day. Intraoperative blood loss and operative duration will be fully documented in real time. Patients will receive telephone follow-up at 1, 2 and 3 months postoperatively. Urinary continence status will be assessed at each contact, and serum PSA testing will be performed regularly to monitor biochemical recurrence, which is defined as sustained PSA levels exceeding 0.1 ng/mL. All perioperative and long-term postoperative complications will be documented in detail. All clinical data will be entered into a standardized electronic database for statistical analyses. The primary endpoint is the rate of urinary continence recovery at 3 months after surgery, while secondary endpoints cover the oncological safety and perioperative risks of the modified procedure. This study aims to verify whether this improved surgical technique can achieve a favorable balance between postoperative urinary functional recovery and oncological tumor control.
- Conditions
- Prostate Cancer
- Being tested
- Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction
- Keywords
- Robot-assisted radical prostatectomy, urinary continence, pelvic fascia reconstruction, anterior urethral suspension
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia ReconstructionProcedure or surgery
This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.
| Study group | Role | What they receive |
|---|---|---|
| Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction | Experimental | This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment. Receives: Procedure: Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early urinanry continence recovery rate
Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
Measured: 3 consecutive months postoperatively
Urinary continence recovery rate
Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
Measured: 3 consecutive months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start12 Dec 2025
- Primary completion10 Jul 2026
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group prospective cohort study. All enrolled patients with localized or locally advanced prostate cancer receive a standardized surgical procedure: modified robot-assisted radical prostatectomy with anterior urethral suspension plus pelvic fascia reconstruction. No control group is established. Telephone follow-ups will be conducted at 1, 2, and 3 months postoperatively to evaluate urinary continence status and monitor biochemical recurrence.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjun Ye, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725653
- Sponsor's protocol ID
- NCC6160
- Acronym
- IAPREA
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anterior Urethral Suspension Combined With Pelvic Fascia Reconstruction During Robot-Assisted Radical Prostatectomy on Early Postoperative Urinary Continence Recovery: A Single-Center, Prospective, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07725653
- Acronym / sponsor ID
- IAPREA / NCC6160
- Conditions
- Prostate Cancer
- Keywords
- Robot-assisted radical prostatectomy, urinary continence, pelvic fascia reconstruction, anterior urethral suspension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 11 Jul 2026 (actual)
- First posted
- 24 Jul 2026 (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 is a single-center prospective cohort study enrolling 60 to 100 patients with prostate cancer treated at The Cancer Hospital of the Chinese Academy of Medical Sciences between December 2025 and July 2026, who will receive modified RARP combined with anterior urethral suspension and pelvic fascia reconstruction. The primary endpoint is the 3-month postoperative urinary continence recovery rate. Secondary endpoints include positive surgical margin rate, intraoperative blood loss, operative duration, postoperative complications, biochemical recurrence and other indicators. Standardized surgical procedures, standardized follow-up and multi-dimensional statistical analyses will be performed to clarify the functional benefits and oncological safety of this modified technique, so as to optimize surgical strategies for locally advanced prostate cancer.
Detailed description
This single-center prospective cohort study will enroll patients with localized and locally advanced prostate cancer at The Cancer Hospital of the Chinese Academy of Medical Sciences from December 2025 to July 2026. All participants will undergo modified robot-assisted radical prostatectomy combining anterior urethral suspension and pelvic fascia reconstruction. Eligible patients are aged 40-75 years with pathologically confirmed T2-T3 prostate cancer, candidates for robotic radical prostatectomy, complete clinical and imaging data, willingness to attend regular follow-up, and signed written informed consent. Exclusion criteria include prior pelvic radiotherapy or prostate surgery, severe organ dysfunction incompatible with general anesthesia, preoperative neurogenic bladder or persistent urinary incontinence, and refusal to complete the full follow-up schedule. All surgeries will be performed by the same senior urologist following standardized protocols. The core modified technique consists of anterior urethral suspension combined with pelvic fascia reconstruction to facilitate early postoperative urinary continence recovery; urinary continence is defined as using no more than one absorbent pad per day. Intraoperative blood loss and operative duration will be fully documented in real time. Patients will receive telephone follow-up at 1, 2 and 3 months postoperatively. Urinary continence status will be assessed at each contact, and serum PSA testing will be performed regularly to monitor biochemical recurrence, which is defined as sustained PSA levels exceeding 0.1 ng/mL. All perioperative and long-term postoperative complications will be documented in detail. All clinical data will be entered into a standardized electronic database for statistical analyses. The primary endpoint is the rate of urinary continence recovery at 3 months after surgery, while secondary endpoints cover the oncological safety and perioperative risks of the modified procedure. This study aims to verify whether this improved surgical technique can achieve a favorable balance between postoperative urinary functional recovery and oncological tumor control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group prospective cohort study. All enrolled patients with localized or locally advanced prostate cancer receive a standardized surgical procedure: modified robot-assisted radical prostatectomy with anterior urethral suspension plus pelvic fascia reconstruction. No control group is established. Telephone follow-ups will be conducted at 1, 2, and 3 months postoperatively to evaluate urinary continence status and monitor biochemical recurrence.
| Arm | Type | Receives |
|---|---|---|
| Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction | Experimental | Procedure: Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia ReconstructionThis single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Pathologically confirmed prostate cancer;
- 2. Scheduled to undergo modified robot-assisted radical prostatectomy;
- 3. Able to complete regular postoperative follow-up and functional assessment;
- 4. Voluntarily sign written informed consent.
Key exclusion criteria (4 listed)
- 1. Previous history of pelvic radiotherapy or prostate surgery;
- 2. Severe cardiac, pulmonary, cerebrovascular, hepatic or renal dysfunction that cannot tolerate general anesthesia and surgery;
- 3. Neurogenic bladder or severe preoperative urinary incontinence;
- 4. Cognitive impairment making follow-up assessment impossible.
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 |
|---|---|---|
| Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia ReconstructionThis single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment. | Procedure or surgery | Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction |
Primary outcome
Early urinanry continence recovery rate
Time frame: 3 consecutive months postoperatively
Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
Urinary continence recovery rate
Time frame: 3 consecutive months postoperatively
Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction in people with Prostate Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early urinanry continence recovery rate (time frame: 3 consecutive months postoperatively). 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 24 Jul 2026.