RecruitingNAINTERVENTIONAL

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

This study is investigating a new, advanced radiation treatment for prostate cancer. It focuses on men with early-stage prostate cancer that hasn't spread. The treatment, called adaptive SBRT, is tailored daily to each patient. A key part of this is protecting the urethra, the tube that allows urine to leave the body, during radiation. The main goal is to see if this approach leads to fewer urinary side effects compared to older radiation methods. Researchers will ask participants about their urinary health using a special questionnaire to measure any changes. It's hoped this precise treatment will make recovery more comfortable for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Varian, a Siemens Healthineers Company

Enrolment target

132

Start

13 Apr 2023

Estimated completion

01 Jul 2031

Prostate Cancer

What is this study about?

This study is looking into a new way to treat prostate cancer called daily adaptive radiation therapy. Think of it like a very precise GPS for your body. Every day before treatment, doctors take a new scan. This helps them see small changes in your body, like if your bladder is a bit fuller or your bowel is in a slightly different position. Based on these daily scans, they adjust the radiation beam very carefully. This makes sure the radiation hits only the cancer and avoids healthy tissues as much as possible.

A special focus of this treatment is protecting your urethra. This is the tube that carries urine from your bladder out of your body. When the prostate gets radiation, the urethra can sometimes get irritated, leading to side effects like needing to pee more often or urgently. By carefully steering the radiation away from the urethra, doctors hope to reduce these common, bothersome side effects.

The main aim of this study is to find out if this new, precise, and protective radiation treatment leads to fewer urinary problems for men with early-stage prostate cancer compared to standard radiation treatments. They will ask participants to fill out questionnaires about their urinary symptoms throughout the study. If successful, this approach could mean a better quality of life for men undergoing prostate cancer treatment.

Key takeaways

Tests a new, highly accurate radiation treatment for early prostate cancer.
Aims to reduce common urinary side effects by protecting the urethra.
Treatment is adjusted daily based on individual body changes.
For men with low to intermediate risk prostate cancer.
Involves regular questionnaires to track urinary symptoms.

Who may be eligible?

This study is for men who have prostate cancer that's considered low or intermediate risk, meaning it's still contained within the prostate and hasn't spread. Your prostate shouldn't be too large, and you should be generally well with no major bowel or bladder issues before starting.

To join, you'll need to be at least 18 years old and able to understand and sign consent forms. You also can't have certain other health conditions, like severe inflammatory bowel disease or other cancers that are being treated with chemotherapy at the same time. You'll need to be able to have an MRI scan and have small markers placed in your prostate.

You won't be able to join if you've had previous radiation treatment in the same area, or certain prostate procedures like having parts of your prostate removed or treated with freezing or high-intensity ultrasound. Also, if your cancer has spread beyond the prostate capsule, or to your lymph nodes, this study would not be suitable 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.

Do I have low or intermediate risk prostate cancer?
Is my prostate cancer still contained and not spread?
Am I generally well, without major bowel or bladder issues?
Am I able to have an MRI scan and small markers placed in my prostate?
Have I not had previous radiation to my pelvis or certain prostate procedures?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the hospital for your daily adaptive radiation therapy. Each day, before your treatment, you would have a scan (like an MRI or CT scan) to help the doctors adjust the radiation perfectly for you. You would then receive your radiation treatment. The exact number of treatment sessions and overall duration will be explained by the study team. Throughout the study, you'd also be asked to complete questionnaires about your urinary symptoms. This helps the researchers understand if the new treatment is reducing side effects. There might be some follow-up appointments after your treatment is finished to continue monitoring your health.

Potential risks and benefits

Potential benefits of taking part include receiving this newer, very precise radiation treatment, which aims to reduce urinary side effects and potentially offer a more comfortable experience during and after treatment. However, as with any medical treatment, there are potential risks, including side effects from radiation, though this study specifically tries to minimise them. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your standard medical care.

Locations (8)

Duarte Cancer Center
Verified postcode
Duarte, United States· Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Verified postcode
Irvine, United States· Recruiting
Brigham and Women's Hospital
Verified postcode
Boston, United States· Active not recruiting
Washington University in St. Louis
Verified postcode
St Louis, United States· Recruiting
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States· Active not recruiting
Klinikum der Landeshauptstadt Stuttgart gKAöR
Verified postcode
Stuttgart, Germany· Recruiting
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
Verified postcode
Homburg, Germany· Recruiting
Hospital Universitario de Navarra
Verified postcode
Pamplona, Spain· Recruiting

Common questions

What is 'adaptive' radiation therapy?

It means the treatment is slightly adjusted every day using new scans, to make sure the radiation hits the cancer precisely and avoids healthy body parts.

Why is 'urethral sparing' important?

The urethra is the tube that carries urine. Protecting it during radiation can help reduce common side effects like needing to pee more often or urgently.

Will this treatment cure my cancer?

This study is testing a new way to deliver radiation for prostate cancer, aiming to reduce side effects. Your doctor can discuss the overall chance of cure with you for your specific cancer stage.

What are 'patient reported acute urinary side effects'?

These are temporary changes in your urinary habits, like going to the toilet more frequently or feeling urgency, that you might notice and report yourself during or soon after treatment.

Do I need any special tests before joining?

Yes, you would need an MRI scan of your prostate and would have small fiducial markers placed in your prostate to help guide the radiation.

How to find out more

Sean Davidson, MASc

sean.davidson@siemens-healthineers.com 1-437-991-8294 Official trial record

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