An interventional study of 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 Prostate Adenocarcinoma and Localized Prostate Carcinoma, sponsored by Shanghai Changzheng Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 480 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques
Procedure: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques
Procedure: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
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.
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.
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.
Time frame: 3 months after surgery
Continence recovery rate
The rate of recovery of continence postoperatively, measured in the number of pads used per day.
Time frame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
PSA
PSA status postoperatively，measured in ng/mL
Time frame: 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）.
Time frame: 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.
Time frame: 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
Time frame: During operation（on an average of 90-120minutes ）
Estimated blood loss
Estimated blood loss, measured in volume (mL)
Time frame: During operation（on an average of 90-120minutes ）
Number of additional ports
Number of additional ports needed in surgery
Time frame: During operation（on an average of 90-120minutes ）
Period of hospitalization
Hospital stay, counted in days from the first day of hospitalization to discharge
Time frame: 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
Time frame: Post surgery, during period of hospitalization (up to 7 days)
Started Jan 2024 (actual). Primary completion is estimated for Jun 2028, 53 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 53 months is above that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
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