RecruitingNAINTERVENTIONAL

Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer

This study is investigating a new way to treat prostate cancer that has returned after previous treatments. It focuses on using a special gel spacer placed between the prostate and the bowel. The goal of this gel is to create more space, protecting the bowel from the powerful X-rays used in a treatment called Stereotactic Ablative Body Radiotherapy (SABR). SABR is a concentrated form of radiation that can be very effective, but it also carries a risk of side effects to the bowel. By using the gel, researchers hope to lower these risks, improve patients' comfort, and make sure their quality of life isn't affected by bowel problems after treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

30 Nov 2021

Estimated completion

30 Nov 2027

Prostate Cancer

What is this study about?

When prostate cancer comes back after initial treatment, doctors look for other ways to tackle it. One of these options is more radiotherapy. However, giving radiation a second time can sometimes cause side effects, especially to the bowel, which is very close to the prostate. These side effects can include discomfort and problems with bowel function.

This study is exploring a way to reduce these problems. It's looking at a special gel, called a hydrogel, which is safely placed between the prostate and the bowel. This gel creates a temporary barrier, pushing the bowel slightly further away from the prostate. This extra space means that when strong, focused radiation, known as SABR, is used to treat the cancer, the bowel is less likely to receive a high dose of radiation.

The main aim is to see if this gel can effectively protect the bowel, making the SABR treatment safer and easier for patients. By reducing potential bowel side effects, the hope is to improve the comfort and quality of life for men who need further radiation treatment for their prostate cancer.

Key takeaways

This study uses a special gel to protect your bowel during prostate cancer radiation.
The treatment targets prostate cancer that has returned after earlier treatments.
The gel creates a space to reduce radiation side effects to your bowel.
The study aims to improve comfort and quality of life for patients.
It involves a precise type of radiation called SABR, given in fewer sessions.
The gel is temporary and naturally absorbed by the body.

Who may be eligible?

To be part of this study, you need to be a man whose prostate cancer has returned after previous treatment, confirmed by tests. You also need to be willing to understand and sign a consent form, and be able to fill out some questionnaires about your health and quality of life.

There are certain reasons why you might not be able to join. For example, if you can't have an MRI scan, or if you take blood-thinning medication that can't be stopped safely. Also, if you have a bleeding disorder, or significant bladder problems already, you might not be suitable. The study also excludes those whose cancer has spread outside the pelvic area or those who have received a very similar, very strong type of radiation treatment before.

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.

Is your prostate cancer confirmed to have returned locally?
Can you have an MRI scan?
Are you able to fill out health questionnaires?
Is your testosterone level not too high if your PSA is elevated?
Has your cancer not spread significantly beyond the pelvic area?
Have you not received a very strong, similar type of radiation previously?

Answer every question to see your result.

What does participation involve?

This study will involve receiving a special gel spacer and then a course of SABR radiation treatment. You'll have regular hospital visits for assessments before, during, and after your treatment. These will include medical check-ups, blood tests, and imaging scans like MRI. You'll also be asked to fill out questionnaires about your bowel and bladder health and overall quality of life at different points. The exact duration of your involvement will depend on the treatment schedule and follow-up plan, but typically for studies like this, follow-up can last for several months to a couple of years.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit here is that the hydrogel spacer might reduce bowel side effects from radiation, potentially improving your comfort and quality of life. However, inserting the gel carries small risks, such as infection or temporary discomfort, and radiation treatment itself has known side effects, though the aim is to reduce them. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sunnybrook Odette Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is SABR?

SABR, or Stereotactic Ablative Body Radiotherapy, is a very precise and strong type of radiation treatment that delivers high doses to the tumour in fewer sessions than traditional radiation.

What does 'salvage' mean in this context?

When cancer returns after initial treatment, any further treatment is called 'salvage treatment' – it's an effort to control the cancer after it has come back.

How is the gel spacer put in?

The gel spacer is usually injected as a liquid through a small needle, often under local anaesthetic, into the space between the prostate and the bowel. It then turns into a soft gel and stays there temporarily.

Is the gel permanent?

No, the gel is biodegradable, meaning it's designed to gradually dissolve and be naturally absorbed by your body over several months after the treatment is complete.

Will I feel the gel after it's in place?

Most patients don't feel the gel working once it's in place. There might be some temporary mild discomfort during the injection.

How to find out more

Amandeep Taggar, MD

aman.taggar@sunnybrook.ca 416 480 6165 Official trial record

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