RecruitingNAINTERVENTIONAL

DEfeating PEnile CAncer-2

This study, called DEPECA-2, is looking at better ways to treat penile cancer by removing affected lymph nodes in the groin. Currently, this is done with open surgery, which can lead to many complications and a difficult recovery. This can sometimes cause delays in other important cancer treatments. Researchers are comparing this standard open surgery with a newer, less invasive method using robotic assistance. Early signs suggest robotic surgery might lead to fewer problems after the operation. The main goal is to find a treatment that is safe, works well against the cancer, and helps patients recover more easily, ultimately improving their overall outcome. This research is also studying cancer markers and other body responses to the surgeries.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

Start

10 Apr 2026

Estimated completion

30 Nov 2031

Penile Cancer Penile Neoplasms Malignant

What is this study about?

Penile cancer is a rare type of cancer in the UK. When it spreads, it often goes to the lymph nodes in the groin area. Removing these lymph nodes is a really important step in treating the cancer and helping patients live longer. The current standard operation for this is called 'open inguinal lymphadenectomy'. While it's good at removing the cancer, it can also lead to many complications, like serious infections or wounds that take a long time to heal. These problems can make recovery very difficult and sometimes delay other important treatments for the cancer.

Because of these complications, doctors sometimes hesitate to recommend the open surgery, which means some patients might not get the crucial treatment they need. Other ways of doing this surgery have been tried before to reduce the complications, but they haven't always worked well enough or safely enough for everyone. This means there's a strong need to find a better, safer way to remove these lymph nodes that still effectively treats the cancer.

This study, DEPECA-2, is looking at a new approach: using robotic assistance for the lymph node removal, called 'robot-assisted inguinal lymphadenectomy'. Early findings from smaller studies suggest that robotic surgery might cause far fewer serious complications – possibly as low as 2% compared to about 30% with traditional open surgery. This study aims to directly compare these two methods in a larger, carefully planned trial to see if robotic surgery is truly a safer option with similar cancer treatment results. The researchers will also be studying how the body reacts to each surgery.

Key takeaways

This study compares standard open surgery with newer robotic surgery for penile cancer.
The surgery removes lymph nodes in the groin to treat the cancer.
A main goal is to find a method with fewer complications and a quicker recovery.
Early findings suggest robotic surgery might have fewer serious problems.
Participation involves being randomly assigned to one of the two surgery types.
This research helps improve future care for men with penile cancer.

Who may be eligible?

To join this study, you must be a man aged 18 or over with penile cancer that has been confirmed by a lab test. Your cancer must be at a stage where doctors recommend removing lymph nodes in the groin, either as a preventative measure because of higher risk, or because cancer has already been detected there. You also need to be well enough to have surgery, meaning your liver, kidneys, and blood markers are healthy enough, and you can attend all necessary study appointments.

You cannot join if your cancer has spread to distant parts of your body, or if you have very large lymph nodes in your groin (4cm or more). You also can't participate if you've already had major surgery, lymph node removal, or radiotherapy in your groin area, or if you are receiving or are planned to receive chemotherapy for your penile cancer before surgery. Finally, you need to be able to understand what taking part in the study means and be willing to follow the study plan carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Do you have confirmed penile cancer?
Has your doctor recommended removing lymph nodes in your groin?
Are you generally healthy enough for surgery?
Do you understand what taking part in a study means?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive one of two types of surgery: either the traditional open lymph node removal or the newer robot-assisted method. You will have regular hospital visits for check-ups and examinations during and after your surgery. There will also be follow-up appointments to monitor your recovery and the success of the treatment. The total duration of your involvement will depend on your individual treatment plan and recovery, but careful monitoring will be ongoing to track your health and the cancer's status.

Potential risks and benefits

Taking part in this study could offer general benefits by helping doctors learn which surgical method is best, potentially leading to improved care for future patients. For you personally, the robotic surgery might lead to fewer complications and a faster recovery compared to traditional open surgery. However, there are also potential risks involved with any surgery, including infection, pain, and other complications, regardless of the method. The study aims to compare these more closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Charité- Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Not yet recruiting
University Hospital Carl Gustav Carus
Verified postcode
Dresden, Germany· Not yet recruiting
Universitätsklinikum Erlangen
Verified postcode
Erlangen, Germany· Not yet recruiting
University Medical Center of Johannes Gutenberg-University
Verified postcode
Mainz, Germany· Not yet recruiting
Medical Faculty Mannheim
Verified postcode
Mannheim, Germany· Not yet recruiting
Ludwig Maximilian University Hospital
Verified postcode
München, Germany· Not yet recruiting
University Medicine Rostock
Verified postcode
Rostock, Germany· Not yet recruiting
University Hospital Tübingen
Verified postcode
Tübingen, Germany· Recruiting
University Hospital Ulm
Verified postcode
Ulm, Germany· Not yet recruiting

Common questions

What is penile cancer?

Penile cancer is a rare type of cancer that affects the penis. It's important to treat it early.

What are lymph nodes?

Lymph nodes are small, bean-shaped glands that are part of your immune system. Cancer can sometimes spread to them.

What is the difference between open surgery and robotic surgery?

Open surgery involves a larger cut, while robotic surgery uses small cuts and special instruments controlled by a surgeon to perform the operation.

Will I get to choose which surgery I have?

No, you will be randomly assigned to either the open surgery or the robotic surgery group, to ensure a fair comparison.

What does 'low rate of complications' mean?

It means the new surgery might cause fewer problems like infections, swelling, or long-term issues compared to the standard operation.

How to find out more

Elizaveta Dimitrievski

elizaveta.dimitrievski@med.uni-tuebingen.de +4970712968257 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.