RecruitingOBSERVATIONAL

THERApy De-escalation for TESTicular Cancer

The THERATEST study is investigating treatment options for a type of testicular cancer called seminoma. Researchers want to collect information from 30 patients in two UK hospitals who are receiving either standard treatments or new treatments that involve fewer strong therapies. This initial study, called a 'feasibility study', will help understand if patients are willing to take part and how these treatments affect their cancer and overall wellbeing. The main goal is to prepare for a larger study by checking if these new treatments show promise and how such a study should be designed. This will help doctors make better decisions about treatment strategies for seminoma in the future.

At a glance

Status

Recruiting

Sponsor

Queen Mary University of London

Enrolment target

Start

24 Jun 2024

Estimated completion

02 Oct 2028

Seminoma

What is this study about?

The THERATEST study is focused on a specific type of testicular cancer called seminoma. Doctors are always looking for the best ways to treat cancer, and sometimes that means trying to find treatments that are just as effective but might have fewer side effects or be less intensive. This study is a first step to explore some of these potentially gentler approaches alongside the standard treatments currently used in hospitals.

Imagine this study as a way to gather important clues. The researchers want to see how patients respond to different treatments – some are the usual ones you might expect, and others are newer, scaled-back options. They'll be observing patients, not telling doctors what to do, but simply collecting information about their journey. This includes how the cancer responds and how patients feel overall, looking at their quality of life. The study involves a small number of patients, and it's happening in two hospitals in the UK.

The main idea behind THERATEST is to prepare the ground for future, larger studies. It’s like testing a recipe in a small kitchen before cooking it for a big banquet. If this initial study shows promising results and that patients are happy to take part, it will help doctors design bigger, more thorough studies. These larger studies would then compare the different treatments directly to find out which ones are truly the best for patients with seminoma. This careful first step ensures that bigger research efforts are well-planned and make the most of valuable resources.

Key takeaways

The study investigates treatment for seminoma, a type of testicular cancer.
It's a small, initial study to see if new, less intensive treatments might work.
Patients' experiences and treatment effectiveness will be observed.
The goal is to help design bigger studies for better future treatments.
It aims to bridge a knowledge gap for doctors treating seminoma.

Who may be eligible?

To join the THERATEST study, you need to be a male aged 16 or older and have a confirmed diagnosis of stage II seminoma, which is a type of testicular cancer. You also need to be willing to give written permission to take part and be able to complete questionnaires about how you're feeling. There are a few other general health checks to make sure the study methods are safe for you.

There are two main groups within the study, depending on the type of de-escalated treatment being considered. For one group, looking at a specific surgery (rRPLND), you would need to have specific levels of cancer markers and meet certain fitness criteria for surgery, including your BMI and heart/lung health. For the other group, looking at a specific chemotherapy called Carboplatin AUC10, you would need to meet different criteria related to your kidney function and cancer markers.

If your alpha-fetoprotein (AFP) cancer marker is too high, or if you're not able to use contraception during treatment, you would not be able to join the study. These are just some of the key requirements, and your doctor would discuss all the details with you to see if you're a good fit.

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 male and aged 16 or over?
Have you been diagnosed with stage II seminoma?
Are you willing to complete questionnaires about your health?
Are your cancer marker levels within specific ranges (to be checked by your doctor)?
Are you generally fit for surgery or chemotherapy as guided by your doctor?
Are you able to use contraception if needed during treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the THERATEST study, your journey would involve following the treatment plan chosen by you and your doctor, which will be one of the standard care options or one of the de-escalated treatments being observed. You won't be told which treatment to have; instead, the study will observe what's decided between you and your healthcare team.

Throughout the study, you'll have regular follow-up appointments, just like you would with your usual cancer care. During these visits, the research team will collect information on how you're responding to treatment and how you are feeling. This will also involve completing questionnaires about your quality of life – these are called patient-reported outcome questionnaires. You will be followed for up to two years after your treatment finishes, or until you decide to stop participating, or if you pass away. After the study period, your follow-up care will continue as part of your hospital's routine checks.

Potential risks and benefits

Taking part in this study means your treatment will be observed closely, which could help your doctors understand how you respond to your care. You might also contribute valuable information that could improve treatment for future patients. Potential risks are generally tied to the treatments themselves, which your doctor will explain in detail, but there are no specific risks from being observed in this study beyond your standard care. Remember, you can choose to leave the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Barts and London Hospital NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'seminoma'?

Seminoma is a common type of testicular cancer that starts in the cells that make sperm.

What does 'de-escalation' mean in this study?

De-escalation means using less intense treatments, if they are shown to be just as effective, to potentially reduce side effects.

Why is this study only for men?

Testicular cancer is a cancer that only affects men, so the study is focused on this specific patient group.

Will my treatment change if I join the study?

No, the study *observes* the current treatment choices made by you and your doctor. It doesn't change what treatment you receive.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and this will not affect your medical care.

How to find out more

Theratest study coordinator

bci-theratest@qmul.ac.uk 020 7882 8478 Official trial record

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