RecruitingPHASE2INTERVENTIONAL

INSPIRE: INnovative SABR for Prostate Cancer All IREland

The INSPIRE study is a research trial exploring an improved type of radiation therapy called SABR for prostate cancer. This new approach uses very focused radiation to treat the cancer while trying to protect healthy tissues nearby, like the urinary tract and rectum, to reduce side effects. It includes special techniques such as using a gel spacer and protecting important nerves. The study is for men with low, intermediate, or certain types of high-risk prostate cancer. Researchers will carefully track how well the treatment works and if it causes fewer side effects than older methods. This information will help doctors offer better care in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Cancer Trials Ireland

Enrolment target

136

Start

01 Apr 2026

Estimated completion

01 Nov 2034

Prostate Adenocarcinoma

What is this study about?

The INSPIRE study is investigating a new, advanced way to deliver radiation therapy for prostate cancer. This treatment is called SABR, which stands for Stereotactic Ablative Radiotherapy. It’s a very precise type of radiation that uses strong, focused beams to target cancer cells while trying to avoid healthy tissue nearby. This study aims to make this treatment even better by using special techniques to further protect important areas like the urinary tract, rectum, and nerves that are important for sexual function.

Doctors are hoping this improved method will treat the cancer effectively while causing fewer side effects than previous radiation treatments. They are particularly interested in seeing if it can reduce problems with urinary function and bowel movements, as well as preserving sexual health. The study will carefully monitor patients throughout the treatment and for several years afterwards to see how they are doing.

This research is important because it could lead to better and safer treatment options for men with prostate cancer. By fine-tuning radiation delivery and protective measures, the goal is to improve the quality of life for patients after their cancer treatment.

Key takeaways

Investigating advanced, precise radiation (SABR) for prostate cancer.
Aims to reduce side effects by protecting healthy tissues.
Includes techniques like a gel spacer to shield the rectum.
For men with low, intermediate, or certain high-risk prostate cancer.
Involves 5 radiation sessions and up to 5 years of follow-up.
Could lead to safer and more effective treatments.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer. Your cancer needs to be a specific type called adenocarcinoma, confirmed by a biopsy, and found within the last 18 months. You would generally be suitable if your general health is good enough for daily activities.

The study is for men with low, intermediate, or certain types of high-risk prostate cancer. This means your cancer hasn't spread widely, and its characteristics (like Gleason score and PSA level) fall within specific ranges. For example, if you have a very aggressive cancer, or one that has spread significantly, this study might not be the right fit for you.

There are also some reasons why you might not be able to join. For instance, if you've had radiation to your pelvic area before, or if you've had certain other cancers in the last two years. Also, if you have severe bowel or bladder problems, or certain metal implants that would interfere with the scans needed for treatment, you might not be eligible. Your doctor will carefully review all these details with 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.

Are you male and 18 years of age or older?
Have you been diagnosed with prostate cancer (adenocarcinoma)?
Is your general health good enough to do most daily activities?
Has your doctor confirmed your prostate cancer is low, intermediate, or an eligible high-risk type?
Have you NOT had previous radiation treatment to your pelvis?
Do you NOT have serious inflammatory bowel disease or significant urinary problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the INSPIRE study, you will first sign a consent form. Before starting treatment, you will undergo several scans and preparations. This includes a CT scan to map out the treatment area. A special gel, called a peri-rectal spacer, will be inserted a week or so before your main planning scans. This gel helps protect your rectum from radiation. You might also have some hormone therapy before, during, or after your radiation, depending on your cancer type, which would be given by your doctor.

The radiation treatment itself will consist of 5 sessions, delivered on alternate days. Each session involves precise targeting using imaging. After your treatment is complete, you'll have regular check-ups. These will involve talking to the doctors about how you feel and filling out questionnaires about your quality of life. These visits will happen at 2, 4, 8, and 12 weeks after treatment, then at 6 and 9 months, and every year for up to 5 years. This allows the medical team to see how well the treatment is working and monitor for any side effects.

Potential risks and benefits

Taking part in this study means you would receive a highly advanced and precise form of radiation therapy that aims to reduce side effects compared to older methods. While the treatment is designed to protect healthy tissues, like all medical treatments, there's always a chance of side effects. These could include temporary changes to your bladder or bowel habits, or effects on sexual function. The study team will closely monitor you for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

St Luke's Centre for Radiation Oncology at Beaumont Hospital
Verified postcode
Dublin, Ireland· Not yet recruiting
Bon Secours - UPMC Hillman
Verified postcode
Cork, Ireland· Recruiting
Northern Ireland Cancer Centre (NICC)
Verified postcode
Belfast, United Kingdom· Not yet recruiting

Common questions

What is SABR?

SABR is a very precise type of radiation treatment that uses strong, focused beams to destroy cancer cells in fewer sessions than traditional radiation.

What is the purpose of the gel spacer?

The gel spacer creates a temporary space between the prostate and the rectum, helping to protect the rectum from radiation and reduce side effects.

Will I receive hormone therapy?

Some patients, especially those with intermediate or high-risk cancer, might receive hormone therapy. Your doctor will discuss if this is right for you.

How long will I be followed after treatment?

You will be followed up with regular checks for up to 5 years after your treatment to monitor your progress and check for any side effects.

What are potential side effects?

While this treatment aims to reduce them, potential side effects could include temporary changes to your bladder or bowel habits, or effects on sexual function.

How to find out more

Cancer Trials Ireland

info@cancertrials.ie +35316677211 Official trial record

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