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Robot surgery may cut complication rates in penile cancer treatment

NCT ID NCT07378670

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether robot-assisted groin lymph node removal causes fewer serious side effects than standard open surgery in 80 men with penile cancer. The goal is to reduce wound healing problems and other complications while still effectively controlling the cancer. Participants are randomly assigned to one of the two surgical approaches and followed for up to 6 months.

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 80 people

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

Started

Apr 2026

Expected to finish

Nov 2031

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 years and older

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\. Patient has provided written informed consent. * 2\. Male patient ≥ 18 years at time of signing the informed consent form. * 3\. Patient has histologically proven penile squamous cell carcinoma. * 4\. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1/2) inguinal lymphadenectomy, i.e.: * pT1a, G2, cN0 OR * pT1b- pT3, any G, cN0 OR * pT1-pT3, any G, cN1-2 * 5\. Patients has adequate hepatic, renal and bone marrow function: * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1.5 x 109 /L * Platelets ≥ 100 x 109 /L * International normalized ratio (INR) / activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants. Anticoagulation is accepted according to the surgeon's practice. * 6\. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations. * 7\. Performance status of the patient is judged by the treating physician as appropriate to undergo surgery. Exclusion Criteria: * 1\. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging). * 2\. Patient has distant metastases. * 3\. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa. * 4\. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or radiotherapy in the groin or pelvic area. * 5\. Patient participates in competing trials affecting the effects of the surgery or outcome measures. * 6\. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences. * 7\. Patient has any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study. * 8\. Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities. * 9\. Patient is unable to consent because he does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.

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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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Charité- Universitätsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, Germany

  • Ludwig Maximilian University Hospital

    NOT_YET_RECRUITING

    München, Germany

  • Medical Faculty Mannheim

    NOT_YET_RECRUITING

    Mannheim, Germany

  • University Hospital Carl Gustav Carus

    NOT_YET_RECRUITING

    Dresden, Germany

  • University Hospital Tübingen

    RECRUITING

    Tübingen, Germany

  • University Hospital Ulm

    NOT_YET_RECRUITING

    Ulm, Germany

  • University Medical Center of Johannes Gutenberg-University

    NOT_YET_RECRUITING

    Mainz, Germany

  • University Medicine Rostock

    NOT_YET_RECRUITING

    Rostock, Germany

  • Universitätsklinikum Erlangen

    NOT_YET_RECRUITING

    Erlangen, Germany

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Other studies related to the condition(s) this trial covers.