Can a single small incision preserve sexual function after prostate cancer surgery?
NCT ID NCT06238713
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial tests whether a newer, single-port robotic surgery for prostate cancer can match or beat the standard multi-port approach in helping men recover sexual function. About 480 men with localized prostate cancer will be randomly assigned to one of the two procedures. Researchers will track how quickly patients regain erectile function and urinary control over the first year after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy techniques
- What this could lead to
- If successful, this approach could offer men with prostate cancer a less invasive surgical option with faster recovery of sexual and urinary function.
- What could go wrong
- This is a surgical technique comparison, not a new treatment. The single-port method may not prove superior or non-inferior to the standard multi-port approach, and individual surgeon skill can influence outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men aged 18 years ≤ age ≤ 75 years; 2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;. 3. Gleason Score\<8. 4. PSA\<20ng/ml. 5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma; 6. The patient has healthy sexual function before surgery and intention for sexual activities after surgery; 7. Physiological condition acceptable for laparoscopic surgery; 8. Willing to cooperate and complete the study follow-up and related examinations; 9. The subject or his agent voluntarily participates in this trial and signs the written informed consent; 10. The questionnaire can be completed in Chinese. 11. The patient has been informed of the trial; Exclusion Criteria: 1. High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA \> 20ng/ml); 2. Special type of prostate cancer, such as neuroendocrine etc.; 3. History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement; 4. Recent surgery of rectum, perianal abscess or around fistula and perineal area; 5. Patients who have undergone previous electro-prostatectomy/enucleation of the prostate; 6. Non-recurrent patients with less than 12 months of follow-up; 7. ECOG\>1. 8. Combination of other systemic tumors; 9. had received any type of preoperative antitumor therapy; 10. 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; 11. Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months; 12. Other conditions that the researchers believe may affect the experimental results or are unethical;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Changzheng hospital
RECRUITINGShanghai, Shanghai Municipality, 201109, China
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- Can surgery boost control of spread prostate cancer?
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- Hormone therapy showdown: can an oral pill beat the shot for prostate cancer patients?