RecruitingNAINTERVENTIONAL

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

This study is for men with prostate cancer who need radiation therapy after surgery. Doctors are looking at different ways to give this radiation, specifically comparing standard radiation with a newer, shorter method called hypofractionated radiotherapy. They're also comparing two types of radiation: photons and protons. The main goal is to see if using protons for this shorter radiation treatment can reduce side effects, particularly those affecting the bowel (rectum), and improve a patient's quality of life. The study also wants to make sure these newer, shorter treatments are just as good at treating the cancer as the longer, standard ones.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

897

Start

12 Sep 2018

Estimated completion

01 Jan 2029

Prostate Cancer

What is this study about?

Prostate cancer is the most common cancer in men. Sometimes, after surgery to remove the prostate, men still need radiation therapy. This extra radiation can be given right away to clear up any remaining cancer cells, or if the cancer starts to show signs of coming back later on. Historically, this radiation treatment has been given over several weeks.

However, doctors have been exploring ways to make radiation treatment shorter. This is called 'hypofractionation', where each daily dose of radiation is stronger, so the overall treatment time is much shorter. Previous studies have shown that this shorter treatment can be safe and effective for prostate cancer that hasn't spread, even after surgery. This new study builds on that knowledge.

This study, called PAROS, aims to compare these different radiation approaches. It's particularly interested in whether using a specific type of radiation called 'protons' in a hypofractionated (shorter) way can reduce common side effects, like problems with the bowel. Improving quality of life by reducing these side effects is the main focus. The study also wants to confirm that these shorter treatments are just as effective at preventing the cancer from returning as the traditional, longer treatments.

Key takeaways

This study compares different radiation treatments for prostate cancer after surgery.
It's looking at shorter radiation courses (hypofractionation) and different radiation types (photons vs. protons).
The main goal is to improve quality of life by reducing treatment side effects, especially with protons.
It also checks if the newer, shorter treatments are just as effective against cancer.
Participation would mean being randomly assigned to a treatment group.

Who may be eligible?

To join this study, you must be a man aged 18 or older with prostate cancer that has been confirmed by a biopsy. You also need to be in good general health, able to carry out most of your usual activities without much trouble, and your doctor must recommend radiation to your prostate area after you've had prostate surgery. This radiation could be given right after surgery or later if your PSA (prostate-specific antigen) levels start to rise again.

However, there are reasons why you might not be able to join. You can't be taking certain hormone therapies, or have cancer that has spread to your lymph nodes or other parts of your body. Also, if the surgeon could still see cancer cells after your operation (meaning the cancer wasn't completely removed), or if you've had radiation treatment to the same area before, you wouldn't be able to participate.

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?
Have you been diagnosed with prostate cancer recently?
Have you had surgery to remove your prostate?
Does your doctor think you need radiation after your prostate surgery?
Do you feel generally well and active?
Has your cancer not spread to other parts of your body or lymph nodes?

Answer every question to see your result.

What does participation involve?

The study involves receiving radiation therapy, either standard or hypofractionated, using either photons or protons, as decided by the study doctors. You will have regular appointments and tests before, during, and after your radiation treatment, which will be similar to what you would typically have with radiation therapy. This will include check-ups and questionnaires to assess your quality of life. The total duration of your participation will depend on the follow-up schedule designed to monitor your health and the cancer's status after treatment.

Potential risks and benefits

Potential benefits of joining this study include receiving advanced radiation treatment that might offer fewer side effects, potentially improving your quality of life during and after treatment. You would also be contributing valuable information that could help future prostate cancer patients. However, like all medical treatments, there are potential risks, including side effects from the radiation itself, which can vary depending on the type and dose used. You will be fully informed of these risks before deciding to participate. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is 'hypofractionated' radiation?

It's a shorter course of radiation therapy where each daily dose is stronger, so the total number of treatment days is reduced.

What's the difference between 'photons' and 'protons'?

Both are types of radiation, but protons may be more precise, potentially delivering less radiation to healthy tissues, which could mean fewer side effects.

What does 'postoperative radiation' mean?

This is radiation therapy given after you've had surgery to remove your prostate due to cancer.

Why is 'quality of life' important in this study?

The study aims to see if newer radiation methods can not only treat cancer effectively but also reduce side effects that impact your daily life, such as bowel issues.

Will I know which treatment I'm getting?

This is a 'randomized' study, meaning you would be assigned to one of the treatment groups by chance, like flipping a coin. You might not know which specific treatment you are receiving.

How to find out more

Juergen Debus

juergen.debus@med.uni-heidelberg.de 06221 56 8201 Official trial record

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