Robot surgery may cut complication rates in penile cancer treatment
NCT ID NCT07378670
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.
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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 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2031
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 years and older
- 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\. 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.
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The places running it
9 sites. 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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Charité- Universitätsmedizin Berlin
NOT_YET_RECRUITINGBerlin, Germany
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Ludwig Maximilian University Hospital
NOT_YET_RECRUITINGMünchen, Germany
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Medical Faculty Mannheim
NOT_YET_RECRUITINGMannheim, Germany
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University Hospital Carl Gustav Carus
NOT_YET_RECRUITINGDresden, Germany
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University Hospital Tübingen
RECRUITINGTübingen, Germany
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University Hospital Ulm
NOT_YET_RECRUITINGUlm, Germany
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University Medical Center of Johannes Gutenberg-University
NOT_YET_RECRUITINGMainz, Germany
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University Medicine Rostock
NOT_YET_RECRUITINGRostock, Germany
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Universitätsklinikum Erlangen
NOT_YET_RECRUITINGErlangen, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Vaccine trains immune system to target HPV-Linked cancers
- Antibody-Drug conjugate aims to hit Hard-to-Treat penile cancer
- Can a targeted drug shrink advanced penile cancer when chemotherapy stops working?
- Can a Two-Drug punch erase penile cancer before surgery?
- Can a single tracer light up cancer's first stop? a trial puts a hybrid dye-and-radioactive marker to the test.
- Penis transplants could restore form and function for wounded warriors