Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)
This study is exploring a new way of giving radiation therapy, called SBRT, to men with prostate cancer that hasn't spread. It's particularly for those who also experience common urinary problems or have an enlarged prostate. The treatment involves five weekly sessions, guided by CT or MRI scans, to make sure the radiation is precisely targeted. The main goal is to check if this method is safe and doesn't cause severe urinary or genital side effects within three months. Researchers want to make sure this shorter treatment option is suitable for more men, especially those who currently might not be offered SBRT due to other health conditions. It's an international study, gathering information from several centres.
At a glance
What is this study about?
This study, called X-SMILE, is looking into a type of radiation treatment called SBRT for prostate cancer. SBRT is a powerful radiation therapy that delivers high doses of radiation over a shorter period, meaning fewer hospital visits compared to traditional radiation. This trial is specifically designed for men whose prostate cancer is still contained within the prostate gland itself, meaning it hasn't spread to other parts of the body.
The interesting part of this study is that it focuses on men who also have other common issues like urinary symptoms (for example, needing to go to the toilet often or difficulty emptying their bladder) or an enlarged prostate. Often, these extra conditions can make SBRT more challenging to use. This study aims to see if a special type of SBRT, where the radiation is adjusted each week using live scans (CT or MRI), can safely and effectively treat their cancer while managing these other conditions.
The main goal is to find out if this weekly, scan-guided SBRT causes severe side effects related to the urinary or genital areas within three months of finishing treatment. By showing it's safe for this group of men, the study hopes to make this more convenient radiation option available to a wider range of patients with prostate cancer.
Key takeaways
- It's about a shorter, 5-week radiation treatment for prostate cancer.
- Specifically for men with urinary issues or an enlarged prostate.
- Uses advanced scans (CT/MRI) weekly to guide the radiation precisely.
- Aims to check if this treatment is safe and effective for these patients.
- Could make advanced radiation accessible to more men.
Who may be eligible?
To be considered for this study, you would need to have prostate cancer that's confirmed by a biopsy and is still contained within your prostate. Your doctors would have decided that SBRT is a suitable treatment plan for you. You also need to be experiencing urinary symptoms, such as a high score on a specific questionnaire about how your bladder is working, or have an enlarged prostate.
There are certain reasons why you might not be able to join. For example, if your prostate cancer is considered very high-risk and requires additional strong hormone treatments, or if the cancer has spread beyond the prostate to other areas like your seminal vesicles or lymph nodes. Previous radiation treatment to your pelvis or prostate, or conditions like inflammatory bowel disease, would also mean you couldn't take part. You also shouldn't have severe urinary blockages that have led to recent urgent medical attention.
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.
- Have I been diagnosed with prostate cancer that hasn't spread?
- Have my doctors suggested SBRT as a treatment option for me?
- Do I have ongoing urinary problems, or has my doctor said I have an enlarged prostate?
- Have I had no previous radiation treatment to my pelvis or prostate?
- Do I have any serious inflammatory bowel conditions?
What does participation involve?
If you take part, you would receive radiation therapy to your prostate once a week for five weeks. This treatment uses highly focused radiation and is guided by CT or MRI scans at each visit to ensure accuracy. The doctors will closely monitor your health and any side effects, especially concerning your urinary and genital health, for at least three months after your last treatment. You would likely have a few follow-up appointments during this time for checks and to answer questionnaires about your symptoms and how you're feeling. The study does not mention any additional medications that would be prescribed specifically for the trial, beyond your standard cancer care.
Potential risks and benefits
Locations (3)
- Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum HeidelbergVerified postcodeHeidelberg, Germany· Not yet recruiting
- Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMUVerified postcodeMunich, Germany· Not yet recruiting
- University Hospital Zurich, Department of Radio-OncologyVerified postcodeZurich, Switzerland· Recruiting
Common questions
What is SBRT?
SBRT is a type of radiation therapy that delivers strong, focused beams of radiation to the cancer in fewer treatment sessions than traditional radiation.
Why is this study specifically for men with urinary problems or an enlarged prostate?
The study wants to find out if this precise, scan-guided SBRT is safe and effective for men who might not usually be offered SBRT due to these other health conditions.
How many radiation treatments will I receive?
You would receive radiation treatment once a week for a total of five weeks.
What kind of scans are used during treatment?
CT or MRI scans are used at each treatment session to guide the radiation and make sure it hits the right spot.
Will I get standard care for my prostate cancer?
Yes, this study uses SBRT as a form of standard care, but with an adapted approach tailor-made for your specific condition (urinary issues/enlarged prostate).
How to find out more
Radiation Oncology Study Office
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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