Can a single small incision preserve sexual function after prostate cancer surgery?

NCT ID NCT06238713

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Male participants only

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Changzheng hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 201109, China

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