Active not recruitingNAINTERVENTIONAL

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer

This study is investigating a new way to protect men from developing bowel problems after radiation treatment for prostate cancer. When men have a specific type of radiation, called Stereotactic Body Radiotherapy (SBRT), it can sometimes affect the bowel because it's very close to the prostate. The study is testing a product called SpaceOAR Vue, which is a special gel that creates a temporary space between the prostate and the bowel. The main goal is to see if using this gel can reduce the chances of developing side effects in the gut later on. This could make radiation treatment more comfortable and reduce long-term issues for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Boston Scientific Corporation

Enrolment target

500

Start

21 Dec 2021

Estimated completion

01 Apr 2030

Prostate Cancer

What is this study about?

This study is about making radiation treatment for prostate cancer safer and more comfortable for men. When prostate cancer is treated with a powerful type of radiation called Stereotactic Body Radiotherapy (SBRT), the radiation targets the prostate gland to kill cancer cells. However, because the prostate sits very close to the bowel (also known as the large intestine), there's a risk that the radiation could also affect the bowel unintentionally.

To help prevent this, researchers are looking at a product called SpaceOAR Vue. Think of SpaceOAR Vue as a temporary gel cushion. It's carefully placed between the prostate and the bowel before the radiation treatment starts. By creating more space between these two organs, the gel acts like a shield, pushing the bowel away from the radiation zone. This means the bowel is less likely to receive a high dose of radiation.

The main aim of this study is to see if using the SpaceOAR Vue gel really helps reduce the chances of men developing late stomach or bowel problems after their SBRT treatment. These problems can include discomfort, changes in bowel habits, or other digestive issues that might appear weeks, months, or even years after treatment. By reducing these side effects, the study hopes to improve the overall quality of life for men undergoing prostate cancer treatment.

Key takeaways

This study evaluates a gel to protect the bowel during prostate cancer radiation.
The gel (SpaceOAR Vue) creates a buffer between the prostate and bowel.
It aims to reduce long-term stomach/bowel side effects from SBRT.
Only men with 'intermediate risk' prostate cancer having SBRT can join.
It could make radiation treatment more comfortable and safer in the long run.

Who may be eligible?

To join this study, you need to be at least 18 years old and have prostate cancer that has been identified by a doctor. Your doctor must be planning for you to have a specific radiation treatment called SBRT, and your cancer should be considered 'intermediate risk'. This means it's not too early, but also not a very advanced stage.

There are also certain things that would mean you can't take part. For example, if your prostate is very large, or if your cancer is in a very advanced stage (like T3 or T4), you wouldn't be able to join. Also, if your blood test results for PSA are too high, or if you have a very aggressive type of cancer based on your biopsy, this study might not be right for you.

Other reasons you might not be suitable include if the cancer has spread to other parts of your body, if you're having treatment for other cancers, or if you've already had certain prostate surgeries or radiation to your lymph nodes. You also can't have had most other types of cancer within the last three years, unless it was a common skin cancer.

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 18 years old or older?
Has your doctor confirmed you have prostate cancer and plan to have SBRT?
Is your prostate cancer considered 'intermediate risk' by your doctor?
Have you *not* had your prostate removed or other specific prostate surgeries?
Has your cancer *not* spread to other parts of your body?
Are you healthy enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

The details of what taking part would involve aren't fully explained here, but generally, in a study like this, you would first have a meeting with the study team to get all the information and decide if you want to join. If you do, you'd sign a consent form. Then, before your radiation treatment starts, you would have the SpaceOAR Vue gel placed between your prostate and bowel as part of your standard preparation for SBRT. During and after your treatment, the study team would regularly check in with you to see how you're feeling and monitor for any side effects, especially those related to your stomach and bowel. This would likely involve appointments and questionnaires over an extended period to track any 'late' side effects, which can appear months after treatment. These follow-up checks are important to see how well the gel is working in the long term. The gel itself is temporary and is naturally absorbed by the body over time.

Potential risks and benefits

Participating in this study might offer potential benefits, such as reducing your risk of experiencing uncomfortable bowel problems that can sometimes happen after prostate radiation. The SpaceOAR Vue system is designed to provide greater protection to your bowel during treatment. However, as with any medical procedure, there are potential risks, though not detailed here, generally these can include risks related to the placement of the gel or potential side effects from the treatment itself. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

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

GenesisCare USA
Verified postcode
Fort Myers, United States
Florida Urology Partners, LLC
Verified postcode
Tampa, United States
Kansas University Medical Center
Verified postcode
Kansas City, United States
GenesisCare USA
Verified postcode
Troy, United States
New Jersey Urology, a Summit Health Company
Verified postcode
Bloomfield, United States
University of Pittsburgh Medical Center
Verified postcode
Pittsburgh, United States
Dr. John Sylvester
Verified postcode
Myrtle Beach, United States
Calvary Mater Newcastle
Verified postcode
Waratah, Australia
Princess Alexandra Hospital - ROPAIR
Verified postcode
Woolloongabba, Australia
Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia
Institut Gustave Roussy
Verified postcode
Villejuif, France
Institut de Radiothérapie & Radiochirurgie HARTMANN
Verified postcode
Levallois-Perret, France

Common questions

What is SpaceOAR Vue?

It's a temporary gel that creates a space between your prostate and bowel during radiation treatment for prostate cancer, helping to protect your bowel.

What is SBRT?

SBRT is a type of radiation treatment for prostate cancer that delivers high doses of radiation to the prostate over a shorter period than traditional radiation.

Why is protecting the bowel important?

The bowel is very close to the prostate, so radiation treatment can sometimes affect it, causing side effects like discomfort or changes in bowel habits.

Will taking part in the study change my prostate cancer treatment?

The study is looking at an addition to your planned SBRT treatment, not changing the SBRT itself. It aims to reduce a potential side effect.

How long will the gel stay in my body?

The gel is temporary and is designed to be naturally absorbed by your body over time after your radiation treatment is complete.