RecruitingPHASE2INTERVENTIONAL

PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND

The PRIMETEST II study is for men aged 18-99 with a specific type of testicular cancer called seminoma, where the cancer has spread a small amount to lymph nodes (stage IIA/B). It's testing a new surgical approach called robot-assisted primary retroperitoneal lymph node dissection (pRA-RPLND). The main goal is to find out if this surgery can reduce the tough, long-term side effects that often come with traditional treatments like chemotherapy and radiotherapy, potentially improving a patient's quality of life. Researchers also want to find better ways to predict which patients will do well with this surgery alone, hoping to offer more personalised care and avoid unnecessary aggressive treatments, while maintaining excellent survival rates.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

Start

28 Aug 2023

Estimated completion

31 Aug 2029

Seminoma

What is this study about?

Testicular cancer is the most common cancer in young men, and thankfully, most men do very well with treatment. However, standard treatments like chemotherapy and radiotherapy can sometimes cause difficult long-term side effects, which can even shorten life by several years. These long-term problems, often affecting the heart, are what doctors are trying to avoid.

This study, called PRIMETEST II, is looking for a kinder way to treat a specific group of men with testicular cancer, particularly those with seminoma that has spread a small amount to the lymph nodes. It follows on from an earlier study, PRIMETEST I, which suggested that a special type of surgery, called robot-assisted primary retroperitoneal lymph node dissection (pRA-RPLND), might be a good option for these men. This surgery uses robotic tools to remove affected lymph nodes, aiming to be precise and less invasive than open surgery.

The main idea behind PRIMETEST II is to see if this robotic surgery can help men avoid the strong chemotherapy or radiotherapy that might cause long-term problems, while still keeping their excellent chances of recovery. The study also aims to discover specific clues (called 'predictive parameters') that can tell doctors which patients are most likely to benefit from this surgery alone, leading to more tailored and gentle treatments. By doing this, the researchers hope to reduce the tough side effects and improve the overall quality of life for young men with this type of cancer.

Key takeaways

This study is for men with a specific type of testicular cancer (seminoma) that has spread slightly.
It tests a new robotic surgery to reduce harsh side effects from traditional treatments.
The aim is to find ways to personalise treatment and improve long-term quality of life.
Participation involves surgery and possibly one cycle of chemotherapy, followed by monitoring.
Researchers hope this approach can prevent long-term health issues linked to chemotherapy and radiation.

Who may be eligible?

This study is looking for men usually between 18 and 99 years old. You might be eligible if you have a specific type of testicular cancer called pure seminoma, and the cancer has spread a small amount to the lymph nodes in your belly (stage IIA or IIB, meaning the spread is up to 5cm). This includes if it's a new diagnosis, or if your stage 1 cancer has come back after being watched closely or after a mild chemotherapy course.

However, you wouldn't be able to join if your lymph node spread is larger than 5cm, or if the cancer has spread to other parts of your body. You also can't participate if you've already had certain strong chemotherapy treatments or radiation therapy to your belly area, or if you have other serious health problems that would make treatment risky. It's also important that your cancer doesn't contain other types of cells apart from seminoma. Before you decide to join, the doctors will do careful checks to make sure this study is right and safe for you.

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.

I am a man aged 18 to 99 years old.
I have been diagnosed with pure seminoma (a type of testicular cancer).
My cancer has spread to lymph nodes, but the largest spread is no bigger than 5cm.
I have not had extensive chemotherapy or radiation to my abdomen previously.
I do not have other serious health problems that would make treatment unsafe.

Answer every question to see your result.

What does participation involve?

If you decide to join PRIMETEST II, you would first have a robot-assisted surgery to remove lymph nodes. Following the surgery, some participants might also receive one cycle of a specific chemotherapy combination. The study isn't detailed about the exact number of visits, but you would have regular check-ups and scans to monitor your health and see how well the treatment is working. This follow-up will likely involve appointments over several years to track your long-term health and ensure any potential recurrence is quickly identified. The total duration of your participation would involve the treatment period and then ongoing monitoring appointments.

Potential risks and benefits

Potential benefits of taking part in this study include the chance to receive a newer type of surgery that aims to reduce long-term side effects often associated with standard chemotherapy or radiotherapy for this type of cancer. This could lead to a better quality of life in the long run. However, as with any medical procedure, there are potential risks, including those related to surgery, anaesthesia, and the chemotherapy given to some participants. While the robotic surgery is designed to be less invasive, complications can still occur. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

University Hospital of Duesseldorf
Verified postcode
Düsseldorf, Germany· Recruiting

Common questions

What is seminoma?

Seminoma is a common type of testicular cancer that often responds very well to treatment, even if it has spread a little.

What does 'robot-assisted' surgery mean?

It means the surgeon uses a special robot to help perform the operation with very precise movements, often through smaller cuts, which can lead to a quicker recovery.

Why are doctors looking for new treatments?

Even though current treatments work well, they can sometimes cause long-term health problems. Doctors want to find kinder ways to treat cancer while keeping success rates high.

Will I definitely avoid chemotherapy if I join?

The goal is to explore if some men can avoid or reduce chemotherapy, but some participants in this study may still receive one cycle of chemotherapy after surgery if needed.

What if my cancer comes back?

The study will closely monitor you. If cancer returns, your doctors will discuss further treatment options with you, as is standard practice.

How to find out more

Yue Che

yue.che@med.uni-duesseldorf.de 00492118118110 Official trial record

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