Overview
- The DEPECA-2 study enrolls patients with penile cancer for whom removal of the lymph nodes in the groin is advisable or necessary.
- Researchers in the study are comparing two surgical methods for removing the lymph nodes in the groin: the standard open surgery and a robot-assisted surgical method.
- The aim of the DEPECA-2 study is to determine whether the robot-assisted method is safer for patients and to compare the results achieved by both methods.
Study status: The study is enrolling patients (recruitment open).
Penile cancer is a rare and aggressive form of cancer. Tumors usually spread quickly and can also affect surrounding lymph nodes. In penile cancer, this often affects the lymph nodes in the groin, that is, the area where the thigh meets the abdomen.
Experts refer to the spread of tumor cells to other organs as metastasis; when they spread to lymph nodes, they are called lymph node metastases. Sometimes lymph node metastases can be felt, but often they are so tiny that this is not possible. About one in four patients with penile cancer has such hidden metastases in the lymph nodes. That is why, in some situations, experts recommend removing not only the tumor itself but also the surrounding lymph nodes through surgery.
This surgery is advisable if:
- the risk is particularly high that the cancer will metastasize to the lymph nodes, or
- the cancer has already metastasized to the lymph nodes. In such cases, doctors remove the lymph nodes to prevent cancer cells from spreading further.
Removing the lymph nodes is therefore an important part of treatment and can improve the life expectancy of patients with penile cancer.
Until now, doctors have typically removed the lymph nodes in the groin through open surgery. This procedure takes place after the tumor on the penis has been removed. To remove the lymph nodes, they make an incision about 8 to 10 centimeters long on each side, through which the lymph nodes are extracted. This is why the procedure is also known as an “open lymph node removal”.
This surgical method has been well studied and has proven effective in treatment. However, complications occur in about one out of every two patients following open lymph node removal, such as:
- infections of the surgical wound,
- problems with wound healing,
- skin necrosis, or
- accumulated lymph fluid (lymphedema).
To reduce the frequency of such complications, researchers are seeking alternative surgical procedures.
In the DEPECA-2 study, scientists are comparing the established open lymph node removal procedure with a robot-assisted surgical method. They are investigating whether smaller incisions and more precise surgery result in fewer complications.
- For more details on the specific goals the scientists are pursuing with the DEPECA-2 study, see the section “What is the aim of the DEPECA-2 study?”.
Patients with penile cancer can participate in the DEPECA-2 study.
Tumors on the penis are usually what are known as squamous cell carcinomas. This means the tumor develops from cells in the outermost layers of the skin or the mucous membrane of the penis.
Only patients for whom removal of the lymph nodes in the groin is medically advisable or necessary can participate in the DEPECA-2 study.
- You can read about the eligibility requirements under “Who is the study suitable for?”.
The full English title of the DEPECA-2 study is: “Robot-assisted vs. open inguinal lymphadenectomy for penile cancer – a prospective randomized trial with a supporting translational program”.
This means:
- In patients with penile cancer, the lymph nodes in the groin are removed, either using open surgery or robot-assisted surgery.
- The goal of the study is to compare the two procedures.
- In addition, the researchers are collecting tissue, blood, and lymph fluid samples for the accompanying scientific program. They are using these samples to investigate how patients’ bodies react to the surgery and whether there are differences depending on the surgical method.
Objectives of the DEPECA-2 Study
The DEPECA-2 study examines how safe robot-assisted surgery is compared to open lymph node removal in people with penile cancer. To this end, the scientists are monitoring how often complications requiring additional treatment occur in the 3 months following surgery.
The researchers also want to determine:
- How long patients require a surgical drain after surgery.
- How long patients survive after surgery.
- How many patients develop a wound infection within 8 months that requires treatment with antibiotics.
- How many patients need to be readmitted to the hospital or undergo another surgery after the operation.
- How many patients experience a recurrence of cancer after surgery.
- How the surgery affects quality of life, recovery, mood, sexuality, pain, and leg swelling.
Patients who meet all of the following criteria may participate in the DEPECA-2 study:
- The patient is male and at least 18 years old.
- The patient has signed a written informed consent form.
- A diagnosis of penile cancer has been confirmed. The cancer must be squamous cell carcinoma.
- The patient is scheduled to undergo surgery to remove the lymph nodes in the groin.
- The patient's kidney, liver, and blood test results do not preclude surgery.
- Doctors assess the patient as being fit enough for surgery to be performed safely.
- The patient is able and willing to attend all scheduled hospital, follow-up, and post-operative care appointments.
When are patients ineligible to participate in the DEPECA-2 study?
- One of the points listed above does not apply.
- The patient has a tumor in the groin that is larger than 4 cm.
- The cancer has spread to organs other than the lymph nodes (distant metastases).
- The patient is receiving chemotherapy prior to surgery or is scheduled to receive it.
- The patient has previously undergone surgery or radiation therapy in the groin or pelvic area. An exception is surgery for an inguinal hernia using keyhole surgery.
- The patient is participating in other clinical trials that could affect the surgery or its outcomes.
- The patient’s health is not good enough for the planned surgery.
- Due to an illness or other circumstances, the patient is unable to assess the nature, scope, and potential consequences of the clinical trial.
The DEPECA-2 study is a:
- Intervention study: Participants are not merely observed but undergo surgery as part of the study. In this intervention study, two surgical methods are compared.
- Randomized trial: In a randomized trial, participants are randomly assigned to either the treatment group or the control group: Half of the participants undergo surgery using the standard method (control group), while the other half undergo surgery using the new method (treatment group).
- Multicenter study: Participants can take part at various study centers in Germany.
- Open-label study: In an open-label study, both the participants and the doctors know which study group the patient has been assigned to.
(1) Initial Consultation and Informed Consent:
During an informational meeting with a study physician, patients learn exactly how the study works. This is also an opportunity to ask questions. The study team then carefully verifies whether the patient meets all the eligibility criteria for participation in the DEPECA-2 study.
If a patient decides to participate in the study, they must sign a consent form.
(2) Preliminary Examinations:
Based on the pre-study examinations, the study team can assess whether the patient is eligible for participation in the study.
At the start of the study, the study team examines and interviews the patients in detail and documents important information and findings regarding their health:
- Personal information such as age and medical history (previous illnesses, tumor stage, date of diagnosis, and prior treatments) is collected.
- In addition, the study team records the patient’s body temperature, height, weight, pulse rate, blood pressure, and general state of health.
- The patient must list which medications they are currently taking or have taken in the past.
- The doctor asks the patient about possible risk factors that could contribute to the disease.
- A doctor will examine and palpate the patient’s groin area and perform an ultrasound examination of this area.
- The study team takes blood samples to check liver, kidney, and thyroid function, as well as complete blood count, blood sugar, blood clotting, blood salts (electrolytes), inflammation markers, and tumor markers.
- The patient provides a urine sample. The study team checks, among other things, the sugar and protein levels.
- A doctor assesses how well the patient copes with daily life and to what extent the disease limits them in their daily activities. This assessment is based on the ECOG status.
- Imaging techniques are used to take images of the chest, abdomen, pelvis, and, if necessary, the brain or bones. Methods that may be used include computed tomography, CT, magnetic resonance imaging, MRI, or PET/CT. Doctors use these images to determine the size of the tumor and whether the cancer has spread throughout the body. If such images are already available, they can be used if they are no older than 28 days.
- Depending on the patient’s condition, doctors may also perform an MRI scan of the head.
- The patient fills out questionnaires covering various topics. These include the patient’s health, pain, quality of life, emotional distress, and sexuality. A support person who assists the patient may also complete the questionnaires. This person must consent to doing so and be present at the appointment at the study center.
Preliminary examinations begin no earlier than 28 days before surgery. This may require several visits to the study center. The treating physicians will try to complete the preliminary examinations as quickly as possible so that the start of treatment is not delayed.
Additional blood samples will be collected before surgery for further scientific research. The researchers will examine and compare various characteristics before and after surgery. This will allow them to observe how these characteristics change over time.
(3) Randomization:
Patients who wish to participate in the study and who meet the eligibility criteria will be randomly assigned to one of two study groups:
- Treatment group: Patients in the treatment group undergo surgery using the robot-assisted method.
- Control group: Patients in the control group undergo surgery using the open surgical method.
Every participant has an equal chance of being assigned to either group. Neither the patients nor the treatment team can influence the assignment.
(4) Lymph Node Removal Surgery
Depending on which study group the patient is assigned to, the lymph nodes are removed either using the standard open surgical method or with the aid of a surgical robot.
- For more information on robot-assisted lymph node removal, see the introduction to this text.
Accompanying Scientific Program:
For further scientific research, the researchers will collect
- a blood sample,
- a sample of lymph fluid, and
- a tissue sample (biopsy).
After the surgery:
The patient must remain in the hospital for a few more days after the surgery. This allows the study team to monitor the patient as closely as possible and treat any complications that may arise. How long a participant stays in the hospital depends, among other things, on the type of surgery and how well the patient recovers afterward.
After surgery, the study team checks the surgical drain every day and records how much fluid is draining. They also record how long the drains are needed after surgery. After the patient is discharged, the drains are checked about once a week.
(5) Study Phase
The study phase begins after surgery and lasts 6 months.
Treatment is based on the recommendations of the medical guidelines for penile cancer. Depending on the findings, this may involve regular examinations. For some patients, surgery to remove additional lymph nodes in the pelvis and/or chemotherapy may be necessary.
For the examinations as part of the study, participants must attend regular appointments at the study center.
These follow-up appointments take place 4 weeks, 3 months, and 6 months after surgery. At each of these appointments, the same examinations are performed as during the preliminary examinations. This allows researchers to compare various aspects of a patient’s health over time.
In addition, 3 days after surgery, the doctors will take a sample of lymph fluid from the surgical drain.
They also draw blood: 4 weeks and 3 months after lymph node removal, as well as whenever the cancer progresses.
The patient also fills out questionnaires designed to assess the severity of pain experienced after the surgery and in the period that follows. The caregiver who filled out the questionnaires at the first appointment is also asked to complete them again at subsequent appointments.
(6) Follow-up Phase
Patients are followed up for a period of 3 years.
The goal is to detect the occurrence of long-term effects of the surgery or metastases at an early stage and to evaluate the long-term success of the treatment.
To this end, the study team examines the participants regularly at the study center. The examinations follow the medical guidelines for penile cancer. These regular appointments usually last about 30 minutes. If imaging procedures (such as computed tomography, CT, or magnetic resonance imaging, MRI) are also performed, participants should plan to spend at least 2 hours at the center.
How often these checkups take place depends on whether the lymph nodes are affected by cancer cells.
If the doctors found cancer cells in the tissue removed during surgery:
- During the first 2 years after surgery: every 3 months
- After that: every 6 months
If the doctors did not find cancer cells in the tissue removed during surgery:
- For the first 2 years after surgery: every 6 months
- After that: once a year
The patient and the caregiver are asked to fill out questionnaires again 12 months after surgery.
(7) End of the Study and Next Steps
After the DEPECA-2 study ends, the study physician will discuss further follow-up care with the patient. This is no longer part of the DEPECA-2 study.
These are the potential benefits of participating in the DEPECA-2 study:
- Researchers suspect that patients who undergo robot-assisted lymph node removal experience fewer complications and recover more quickly after surgery. However, this is not certain, as it is the subject of this study.
- By participating, patients support cancer research and help generate new insights that may benefit future patients with penile cancer.
However, participating in the DEPECA-2 study may also involve some risks:
- Since the surgery and most of the tests are part of standard treatment, participation in the study involves only minimal additional risks. A study physician will explain the risks during the informed consent discussion.
Specific risks of open lymph node removal:
- Open lymph node removal is a major surgical procedure. As a result, patients’ recovery time may take comparatively longer.
- The risk of complications is increased due to the larger skin incisions. Infections, bleeding, pain, tissue necrosis, or lymphatic congestion may occur.
Specific risks of robot-assisted lymph node removal:
- Surgery using a surgical robot may lead to technical difficulties or injuries caused by the robot’s arms. However, these are very rare.
- Preparation and the surgery itself may take longer. A longer surgery time increases the risk of complications. This also depends on individual risk factors.
Where is the study being conducted?
The DEPECA-2 study is scheduled to take place at 9 different sites in Germany. Currently, patients can participate at the University Hospital of Tübingen.
What costs will participants incur?
Participation in the trial is free of charge for patients. However, you will not receive any compensation for your time or expenses. Travel expenses are not reimbursed as part of the trial. All examinations conducted as part of the trial are free of charge.
If you have questions about the study’s funding, you can ask the study team, for example, during the initial consultation.
How many participants will the study accept? Are there still places available?
The DEPECA-2 study is enrolling a total of 80 patients.
Patients can find out directly from the study centers where spots are still available.
How can I register?
The study physicians will approach suitable patients about participating in the DEPECA-2 study. Alternatively, interested individuals can also inquire at the study centers.
Those interested can contact the University Clinic for Urology in Tübingen by email.
Interested parties can find more information about the DEPECA-2 study on the website of the Department of Urology at the University of Tübingen.
The DEPECA-2 study is supported by patient representatives from the Bundesverband Prostataselbsthilfe e.V. and by NCT Südwest.
Scientific Publications (Selection)
Singh A, Jaipuria J, Goel A, Shah S, Bhardwaj R, Baidya S, Jain J, Jain C, Rawal S. Comparing Outcomes of Robotic and Open Inguinal Lymph Node Dissection in Patients with Carcinoma of the Penis. J Urol. 2018 Jun;199(6):1518-1525. doi: 10.1016/j.juro.2017.12.061.
Stuiver MM, Djajadiningrat RS, Graafland NM, Vincent AD, Lucas C, Horenblas S. Early wound complications after inguinal lymphadenectomy in penile cancer: a historical cohort study and risk-factor analysis. Eur Urol. 2013;64(3):486-92. doi: 10.1016/j.eururo.2013.02.037.
Thomas A, Kölling F, Haferkamp A, Tsaur I. Qualitätskriterien in der Therapie des Peniskarzinoms [Quality of care criteria in the treatment of penile cancer]. Urologe A. 2021 Feb;60(2):186-192. German. doi: 10.1007/s00120-020-01429-w.
This study description was prepared by authors from the Cancer Information Service, under the direction of Dr. S. Weg-Remers, based on the study documentation.