DEfeating PEnile CAncer-2

Summary

Open inguinal lymphadenectomy (O-ILAD) is the current standard of care for invasive staging and simultaneously the curative approach for patients with PeCa and elevated risk for or clinically detectable lymphatic disease in the groin. The high rate of complications of this surgical procedure, which are often mutilating and associated with a long-term convalescence, leads to a critical delay in initiation of adjuvant systemic therapy. Being in apprehension of these postsurgical adversities, physicians are often reluctant with indicating this procedure, thus depriving their patients of the vital prognosis-relevant care. In the sum, these obstacles inevitably result in inferior oncologic outcomes. Aiming to decrease postsurgical detrimental sequelae, several attempts to modify radicality of the technique, including inter alia a radioguided approach of sentinel lymph node resection, have been presented in the last decades. Unfortunately, utilization of the sentinel lymph node technique outside of a few highly specialized referral centers is prone to a significant false negativity, while other approaches are associated with inconsistent oncological and perioperative outcomes, hence precluding a general breakthrough in the surgical management of the groin lymph nodes. Thus, a high unmet medical need exists for the establishment of an approach with the lowest possible rate of complications and at the same time the optimal oncological safety. In this context, preliminary evidence from small sample studies points to a promising potential of minimally invasive surgery to be further tested in the setting of inguinal lymphadenectomy. A recent retrospective single-center report on robot-assisted inguinal lymphadenectomy (R-ILAD) showed that the rate of major complications was only as low as 2%. On the contrary, the rate of major complications in our own and other O-ILAD series was approx. 30%. DEPECA-2 is a prospective randomized multicenter trial, in which R-ILAD will be tested vs. O-ILAD on the 1b level of evidence for the first time. The scientific value of the project is significantly substantiated by a comprehensive translational research program, which includes inflammatory and oncologic biomarker research, as well as functional validation in preclinical models. The results of this trial will foster further optimization of outcomes in the surgical management of PeCa.

Eligibility

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.

Conditions3

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