Active not recruitingNAINTERVENTIONAL

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

This study is testing a new way to treat prostate cancer called MRI-guided radiation therapy. Currently, radiation treatment often takes many weeks, with daily visits. This new approach aims to shorten that to just five treatment sessions, guided by MRI scans. The study wants to find out if this much quicker treatment is safe and effective for men with certain types of prostate cancer. It’s important because finding shorter, yet equally good, ways to treat cancer can make a big difference to patients' lives. This research is collecting information to see if this shorter method could become a standard treatment option in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

Start

25 Mar 2021

Estimated completion

25 Mar 2028

Prostate Cancer

What is this study about?

Prostate cancer is a very common cancer in men. When detected early and hasn't spread, there are a few main ways to treat it. One common method is surgery, and another is radiotherapy, which uses high-energy beams to kill cancer cells. Currently, radiotherapy often means having treatment visits almost every day for about seven to eight weeks, which can be a long and tiring process for patients.

Doctors are always looking for ways to make treatments better and easier. Over time, they've found that sometimes, giving higher doses of radiation in fewer visits (a method called 'hypofractionation') can be just as effective. This study is taking that idea further, trying to see if an even shorter treatment, specifically five sessions, works. They are using a special type of radiation called MR-guided radiotherapy, where an MRI scanner helps doctors aim the radiation very precisely at the cancer.

The main goal of this particular study, called SMILE, is to check if this super-shortened, five-session MRI-guided radiotherapy is safe and if it can be done successfully. If it is, it could mean men with prostate cancer might be able to complete their radiation treatment much faster, with fewer hospital visits, while still getting excellent care. This could significantly improve quality of life during treatment.

Key takeaways

This study explores a very short prostate cancer treatment (5 sessions).
It uses MRI to guide radiation precisely.
Aims to be safer and quicker than standard long radiation.
Only for certain types of prostate cancer that hasn't spread.
If successful, it could offer a new, faster treatment option.

Who may be eligible?

This study is designed for men who have been diagnosed with prostate cancer that hasn't spread to other parts of the body. Specifically, it's for those with a low, intermediate, or early high-risk type of prostate cancer. Your doctor will use specific tests and scores to determine if your cancer fits these categories.

To be considered, you also need to be aged 18 or older and generally in good health, meaning you can carry out most of your daily activities without much trouble. Your prostate size also needs to be below a certain limit, and you shouldn't have too many bladder or urine-related symptoms. It's really important that you understand what the study involves and are happy to give your written consent to take part.

However, you won't be able to join if you've had radiation treatment in your pelvic area before, or if you've already had other local treatments for your prostate. If the cancer has spread to your lymph nodes or other distant parts of your body, you also won't be eligible. Also, if you can't have an MRI scan or are already taking part in another study that might affect these results, you wouldn't be able to join this one.

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.

Have you been diagnosed with prostate cancer?
Has your doctor said your prostate cancer is low, intermediate, or early high-risk?
Are you 18 years old or older?
Have you *not* had radiation or other local treatments for your prostate before?
Is your cancer *not* spread to lymph nodes or other parts of your body?
Can you have an MRI scan?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive MRI-guided radiation therapy for your prostate cancer. This involves attending treatment sessions, which are planned to be completed over just five visits. During these sessions, an MRI scanner will be used to help guide the radiation accurately to your prostate.

You'll have regular checks and assessments with the study team before, during, and after your treatment to monitor your health and how the treatment is working. This will involve appointments to measure how you're feeling, conduct physical examinations, and take blood tests. The total duration of your participation will include these treatment sessions and follow-up checks to understand the long-term effects of the shortened therapy.

Potential risks and benefits

Participating in this study might offer the benefit of a much shorter prostate cancer treatment, reducing the number of hospital visits and potentially making the treatment process less disruptive to your daily life. However, as with any new treatment approach, there are potential risks. Because this is a shorter, more intense radiation schedule, there might be side effects, some of which could be unknown or different from standard radiation. You will be closely monitored for any such effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital of Heidelberg, Radiation Oncology
Verified postcode
Heidelberg, Germany

Common questions

What is MRI-guided radiation?

It's a special type of radiation therapy where an MRI scanner is used to precisely see the prostate during treatment, helping doctors aim the radiation very accurately.

How is this different from standard radiation?

Standard radiation for prostate cancer usually takes many weeks (7-8), with daily visits. This study aims to complete treatment in just five sessions, guided by MRI.

Will this treatment hurt?

Radiation therapy itself doesn't cause pain during the treatment session. However, you might experience side effects like tiredness or changes in bladder/bowel habits later on, which the study team will discuss with you.

Why only men in this study?

This study is specifically for prostate cancer, which only affects men.

What happens if I change my mind about participating?

You are free to leave the study at any time, for any reason, and it will not affect your future medical care.