Urologic CancerNCT07305142
Comparison of the Integrated Posterior-Anterior-Lateral Approach and the Posterior Approach in Robotic Radical Prostatectomy
A study testing PAL combined approach group and posterior approach group in people with Urologic Cancer and Prostate, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was: What is the early therapeutic… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Urologic Cancer, Prostate, Robot Assisted Laparoscopic Radical Prostatectomy
- What is being tested?
- PAL combined approach group and posterior approach group
- 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
- 16 May 2024to 2 Dec 2025
- 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
- Prostate biopsy confirms prostate cancer;
- Clinical T stage <=T3a stage;
- Fully understand clinical trial protocols and sign informed consent;
Who cannot join
- Urinary incontinence before surgery;
- Previous endoscopic prostate surgery;
- There are serious underlying diseases that cannot tolerate surgery or have a survival of less than 5 years;
- Metastatic disease is present or lymph node involvement is suspected at diagnosis;
- Patients judged by the investigator to be unsuitable for participation in this clinical trial;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Prospective, Randomized Controlled Study Comparing the Integrated Posterior-Anterior-Lateral (PAL) Approach and the Posterior Approach in Robot-Assisted Radical Prostatectomy: Evaluation of Perioperative Outcomes, Postoperative Functional Recovery, and Oncologic Control
This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was:
What is the early therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy using the combined posterior, anterior, and lateral (PAL) approach, and how does it compare with the traditional posterior approach? Participants were randomly assigned to undergo either robot-assisted laparoscopic radical prostatectomy using the PAL (posterior-anterior-lateral) approach or the classic posterior approach.
- Being tested
- PAL combined approach group, posterior approach group
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAL combined approach groupProcedure or surgery
PAL combined approach was performed to resect the prostate
posterior approach groupProcedure or surgery
Intraoperative resection of the prostate was performed by posterior approach
| Study group | Role | What they receive |
|---|---|---|
| PAL-RAPA | Active comparator | Participants undergo robot-assisted laparoscopic radical prostatectomy(RAPA) via an integrated Posterior-Anterior-Lateral (PAL) approach using the da Vinci system.
* Posterior:** mobilize sigmoid colon, incise rectovesical peritoneum, dissect vas deferens and seminal vesicles, open Denonvilliers' fascia, create a fascial window at prostate base.
* Anterior:** enter retropubic space, preserve endopelvic fascia, puboprostatic ligaments, dorsal venous complex, expose bladder neck and anterior prostate.
* Lateral:** dissect lateral bladder neck/prostate base, expand triangular space, retract seminal vesicle through posterior window, incise bladder neck, control vascular pedicles, perform atraumatic neurovascular bundle dissection, preserve urethral length.
* Prostate removal is followed by continuous urethrovesical anastomosis** with 3-0 barbed suture.
Intended Purpose of Intervention: Assess perioperative outcomes, early functional recovery, and oncologic safety of PAL-RAPA Receives: Procedure: PAL combined approach group |
| Posterior RAPA | Active comparator | Participants undergo robot-assisted laparoscopic radical prostatectomy via a posterior-only approach using the da Vinci system. The procedure includes: mobilization of the sigmoid colon, incision of the rectovesical peritoneum, dissection of vas deferens and seminal vesicles, opening of Denonvilliers' fascia, and creation of a fascial window at the prostate base. Prostate removal is followed by continuous urethrovesical anastomosis using a 3-0 barbed suture. Receives: Procedure: posterior approach group |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary continence
was defined as the use of zero to one safety pad per day without any involuntary leakage.Immediate continence was defined as continence within seven days after catheter removal, while early continence was defined as continence achieved within three months.
Measured: Patients were assessed for urinary incontinence, defined according to established criteria, via telephone at five time points after the removal of the urinary catheter (which was 2-3 weeks post-surgery): within 7 days, and at 1, 3, 6, and 12 months.
Secondary outcomes (4)
Operation time
Measured: During operation
Estimated blood loss
Measured: During operation
Complications
Complications were classified according to the Clavien-Dindo system, and those of grade II or higher were documented in this study.
Measured: Perioperative
Time for removal of drainage tube
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start16 May 2024
- Primary completion1 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuepei Zhang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305142
- Sponsor's protocol ID
- 2024-KY-0820-002
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study Comparing the Integrated Posterior-Anterior-Lateral (PAL) Approach and the Posterior Approach in Robot-Assisted Radical Prostatectomy: Evaluation of Perioperative Outcomes, Postoperative Functional Recovery, and Oncologic Control
- ClinicalTrials.gov ID
- NCT07305142
- Acronym / sponsor ID
- 2024-KY-0820-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 26 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.
This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was:
What is the early therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy using the combined posterior, anterior, and lateral (PAL) approach, and how does it compare with the traditional posterior approach? Participants were randomly assigned to undergo either robot-assisted laparoscopic radical prostatectomy using the PAL (posterior-anterior-lateral) approach or the classic posterior approach.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAL-RAPA | Active comparator | Procedure: PAL combined approach groupParticipants undergo robot-assisted laparoscopic radical prostatectomy(RAPA) via an integrated Posterior-Anterior-Lateral (PAL) approach using the da Vinci system. * Posterior:** mobilize sigmoid colon, incise rectovesical peritoneum, dissect vas deferens and seminal vesicles, open Denonvilliers' fascia, create a fascial window at prostate base. * Anterior:** enter retropubic space, preserve endopelvic fascia, puboprostatic ligaments, dorsal venous complex, expose bladder neck and anterior prostate. * Lateral:** dissect lateral bladder neck/prostate base, expand triangular space, retract seminal vesicle through posterior window, incise bladder neck, control vascular pedicles, perform atraumatic neurovascular bundle dissection, preserve urethral length. * Prostate removal is followed by continuous urethrovesical anastomosis** with 3-0 barbed suture. Intended Purpose of Intervention: Assess perioperative outcomes, early functional recovery, and oncologic safety of PAL-RAPA |
| Posterior RAPA | Active comparator | Procedure: posterior approach groupParticipants undergo robot-assisted laparoscopic radical prostatectomy via a posterior-only approach using the da Vinci system. The procedure includes: mobilization of the sigmoid colon, incision of the rectovesical peritoneum, dissection of vas deferens and seminal vesicles, opening of Denonvilliers' fascia, and creation of a fascial window at the prostate base. Prostate removal is followed by continuous urethrovesical anastomosis using a 3-0 barbed suture. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prostate biopsy confirms prostate cancer;
- Clinical T stage <=T3a stage;
- Fully understand clinical trial protocols and sign informed consent;
Key exclusion criteria (5 listed)
- Urinary incontinence before surgery;
- Previous endoscopic prostate surgery;
- There are serious underlying diseases that cannot tolerate surgery or have a survival of less than 5 years;
- Metastatic disease is present or lymph node involvement is suspected at diagnosis;
- Patients judged by the investigator to be unsuitable for participation in this clinical trial;
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 |
|---|---|---|
| PAL combined approach groupPAL combined approach was performed to resect the prostate | Procedure or surgery | PAL-RAPA |
| posterior approach groupIntraoperative resection of the prostate was performed by posterior approach | Procedure or surgery | Posterior RAPA |
Primary outcome
urinary continence
Time frame: Patients were assessed for urinary incontinence, defined according to established criteria, via telephone at five time points after the removal of the urinary catheter (which was 2-3 weeks post-surgery): within 7 days, and at 1, 3, 6, and 12 months.
was defined as the use of zero to one safety pad per day without any involuntary leakage.Immediate continence was defined as continence within seven days after catheter removal, while early continence was defined as continence achieved within three months.
4 secondary outcomes
Operation time
Time frame: During operation
Estimated blood loss
Time frame: During operation
Complications
Time frame: Perioperative
Time for removal of drainage tube
Time frame: Perioperative
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 26 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Urologic Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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 PAL combined approach group and posterior approach group in people with Urologic Cancer and Prostate, run by The First Affiliated Hospital of Zhengzhou 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 3 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: finished, as of the sponsor's last update on 26 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?
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?
urinary continence (time frame: Patients were assessed for urinary incontinence, defined according to established criteria, via telephone at five time points after the removal of the urinary catheter (which was 2-3 weeks post-surgery): within 7 days, and at 1, 3, 6, and 12 months.). 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 26 Dec 2025.