Comparing open and robot-assisted removal of groin lymph nodes for penile cancer

Robot-assisted vs. Open Inguinal Lymphadenectomy for Penile Cancer - a Prospective Randomized Trial With a Supporting Translational Program

This trial will test whether robot-assisted groin lymph node removal causes fewer complications and faster recovery than standard open surgery for men with penile squamous cell carcinoma who need lymphadenectomy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Hospital Tuebingen (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Berlin and 8 other locations)
• Trial ID: NCT07378670 on ClinicalTrials.gov

What this trial studies

This multicenter surgical comparison looks at outcomes after traditional open inguinal lymphadenectomy versus a robot-assisted minimally invasive approach in men requiring groin lymph node removal for penile squamous cell carcinoma. Eligible patients who have an indication for prophylactic or therapeutic inguinal lymphadenectomy will undergo one of the two surgical techniques and be followed for postoperative complications, wound morbidity, time to recovery, and timing of any adjuvant therapy. The trial will also record nodal staging, recurrence patterns, and other oncologic outcomes. The overall goal is to see if a robot-assisted approach can reduce the high complication rates and long convalescence associated with open surgery.

Who should consider this trial

Good fit: Men aged 18 or older with histologically confirmed penile squamous cell carcinoma who need prophylactic (intermediate/high-risk cN0) or therapeutic (cN1–cN2) inguinal lymphadenectomy are the intended participants.

Not a fit: Patients with non-squamous penile tumors, widely metastatic or unresectable disease, or those who are medically unfit for surgery are unlikely to benefit from this surgical comparison.

Why it matters

Potential benefit: If successful, the robot-assisted approach could reduce surgical complications, shorten recovery, and allow earlier initiation of adjuvant therapy, improving quality of life and potentially oncologic outcomes.

How similar studies have performed: Small series and single-center reports of minimally invasive and robot-assisted inguinal lymphadenectomy show promising reductions in wound complications, but high-quality randomized evidence is still limited.

Eligibility criteria

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.

Where this trial is running

Berlin and 8 other locations

• Charité- Universitätsmedizin Berlin — Berlin, Germany (Not_yet_recruiting)
• University Hospital Carl Gustav Carus — Dresden, Germany (Not_yet_recruiting)
• Universitätsklinikum Erlangen — Erlangen, Germany (Not_yet_recruiting)
• University Medical Center of Johannes Gutenberg-University — Mainz, Germany (Not_yet_recruiting)
• Medical Faculty Mannheim — Mannheim, Germany (Not_yet_recruiting)
• Ludwig Maximilian University Hospital — München, Germany (Not_yet_recruiting)
• University Medicine Rostock — Rostock, Germany (Not_yet_recruiting)
• University Hospital Tübingen — Tübingen, Germany (Recruiting)
• University Hospital Ulm — Ulm, Germany (Not_yet_recruiting)

Study contacts

• Principal investigator: Igor Tsaur, Prof. Dr. — University Hospital Tuebingen, Medical Faculty, Eberhard-Karls-University
• Study coordinator: Elizaveta Dimitrievski

Conditions Penile Cancer; Penile Neoplasms Malignant; robotic inguinal lymph node dissection; inguinal lymphadenectomy; surgical outcome