Prostate AdenocarcinomaNCT06238713
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
A study testing Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques and Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques in people with Prostate Adenocarcinoma and Localized Prostate Carcinoma, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Localized Prostate Carcinoma
- What is being tested?
- Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques and Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to Dec 2028
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18 years ≤ age ≤ 75 years;
- Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.
- Gleason Score<8.
- PSA<20ng/ml.
- Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;
- The patient has healthy sexual function before surgery and intention for sexual activities after surgery;
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- Physiological condition acceptable for laparoscopic surgery;
- Willing to cooperate and complete the study follow-up and related examinations;
- The subject or his agent voluntarily participates in this trial and signs the written informed consent;
- The questionnaire can be completed in Chinese.
- The patient has been informed of the trial;
Who cannot join
- High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA > 20ng/ml);
- Special type of prostate cancer， such as neuroendocrine etc.;
- History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
- Recent surgery of rectum, perianal abscess or around fistula and perineal area;
- Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
- Non-recurrent patients with less than 12 months of follow-up;
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- ECOG>1.
- Combination of other systemic tumors;
- had received any type of preoperative antitumor therapy;
- Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;
- Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;
- Other conditions that the researchers believe may affect the experimental results or are unethical;
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
Changzheng hospital
Shanghai, Shanghai Municipality, 201109
Shancheng Ren, PhD, 13917793885, renshancheng@gmail.com
About this study
This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
Read the detailed description
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.
- Being tested
- Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques, Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
- Keywords
- Prostate Cancer, Robotic-assisted Radical Prostatectomy, da Vinci surgical robot, Potency, Non-inferiority, RCT, Continence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniquesProcedure or surgery
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniquesProcedure or surgery
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Single-port extraperitoneal RARP | Experimental | Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques Receives: Procedure: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques |
| Multi-port transperitoneal RARP | Active comparator | Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques Receives: Procedure: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potency recovery rate
Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.
Measured: 3 months after surgery
Secondary outcomes (9)
Continence recovery rate
The rate of recovery of continence postoperatively, measured in the number of pads used per day.
Measured: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
PSA
PSA status postoperatively，measured in ng/mL
Measured: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
Potency recovery rate
Potency recovery rate will be assessed by patient's self-reported erectile firmness for sexual activity or intercourse, International Index of Erectile Dysfunction(IIEF-5) score（from 0-25 score, a higher score means a worse outcome）, and phosphodiesterase5 (PDE-5）inhibitor intake frequency according to patients' despciption (a higher intake means a worse outcome）.
Measured: Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively
Clavien-Dindo complication score
Clavien-Dindo complication score measured in the following grades（a higher grade means a worse outcome） ： First grade：complications that do not require medication, surgery or endoscopic treatment.
Second grade： complications require to be treated with drugs, including blood transfusion and parenteral nutrition.
Third grade： complications that require surgery, endoscopy, or radiation therapy.
Fourth grade: the emergence of life-threatening complications, including cerebral hemorrhage, etc., which is also divided into 4a and 4b, 4a is single-organ dysfunction, 4b is mainly multi-organ dysfunction and injury.
Fifth grade: death.
Measured: Every day during period of hospitalization (up to 7 days)
Operative time
Time elapsed from skin incision to placement of the final skin suture, measured in minutes
Measured: During operation（on an average of 90-120minutes ）
Estimated blood loss
Estimated blood loss, measured in volume (mL)
Measured: During operation（on an average of 90-120minutes ）
Number of additional ports
Number of additional ports needed in surgery
Measured: During operation（on an average of 90-120minutes ）
Period of hospitalization
Hospital stay, counted in days from the first day of hospitalization to discharge
Measured: During period of hospitalization (up to 7 days)
Period of hospitalization post surgery
Hospital stay, counted in days from the time of transfer to the post anesthesia care unit (PACU) to discharge
Measured: Post surgery, during period of hospitalization (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start8 Jan 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, ShuGuang Hospital, Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Guangzhou Medical University, Sir Run Run Shaw Hospital, Sichuan Provincial People's Hospital
- Responsible party
- Principal investigator, Ren Shancheng, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238713
- Sponsor's protocol ID
- SINO-TOP-23
- Status last verified
- Jul 2026
- First submitted
- 15 Jan 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
- ClinicalTrials.gov ID
- NCT06238713
- Acronym / sponsor ID
- SINO-TOP-23
- Keywords
- Prostate Cancer, Robotic-assisted Radical Prostatectomy, da Vinci surgical robot, Potency, Non-inferiority, RCT, Continence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, ShuGuang Hospital, Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Guangzhou Medical University, Sir Run Run Shaw Hospital, Sichuan Provincial People's Hospital
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Feb 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 is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
Detailed description
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port extraperitoneal RARP | Experimental | Procedure: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniquesSingle-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques |
| Multi-port transperitoneal RARP | Active comparator | Procedure: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniquesMulti-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men aged 18 years ≤ age ≤ 75 years;
- Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.
- Gleason Score<8.
- PSA<20ng/ml.
- Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;
Key exclusion criteria (12 listed)
- High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA > 20ng/ml);
- Special type of prostate cancer， such as neuroendocrine etc.;
- History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
- Recent surgery of rectum, perianal abscess or around fistula and perineal area;
- Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
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 |
|---|---|---|
| Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniquesPatients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up. | Procedure or surgery | Single-port extraperitoneal RARP |
| Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniquesPatients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up. | Procedure or surgery | Multi-port transperitoneal RARP |
Primary outcome
Potency recovery rate
Time frame: 3 months after surgery
Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.
9 secondary outcomes
Continence recovery rate
Time frame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
PSA
Time frame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
Potency recovery rate
Time frame: Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively
Clavien-Dindo complication score
Time frame: Every day during period of hospitalization (up to 7 days)
Operative time
Time frame: During operation（on an average of 90-120minutes ）
Estimated blood loss
Time frame: During operation（on an average of 90-120minutes ）
Number of additional ports
Time frame: During operation（on an average of 90-120minutes ）
Period of hospitalization
Time frame: During period of hospitalization (up to 7 days)
Period of hospitalization post surgery
Time frame: Post surgery, during period of hospitalization (up to 7 days)
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 23 Jul 2026.
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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 Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques and Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques in people with Prostate Adenocarcinoma and Localized Prostate Carcinoma, run by Shanghai Changzheng Hospital 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 11 inclusion and 12 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 23 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?
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 Shancheng Ren, MD/PhD (021-81886999, renshancheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potency recovery rate (time frame: 3 months after surgery). 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 23 Jul 2026.