RecruitingPHASE2INTERVENTIONAL

Dose Escalation For INtraprostatic LEsions

This study, called 'Dose Escalation For Intraprostatic Lesions', is looking at a new way to treat prostate cancer using radiotherapy. Currently, radiotherapy is given in many small doses over several weeks. This study uses a new approach where treatment is given in just three larger doses over one week, guided by detailed MRI scans that pinpoint the exact location of the cancer. This targeted approach, called a 'focal boost', aims to deliver a stronger treatment directly to the tumour while sparing healthy tissue. The main goal is to check if this new method is safe, meaning it doesn't cause more bowel or bladder side effects than standard treatment, and if it could potentially reduce the chances of the cancer coming back.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ottawa Hospital Research Institute

Enrolment target

Start

23 Nov 2023

Estimated completion

01 Jun 2028

Prostatic Neoplasms

What is this study about?

If you have prostate cancer that hasn't spread, your doctor might suggest treatments like radiotherapy. Often, this involves daily treatment sessions over about four weeks, where the whole prostate gland receives the same dose of radiation. This is a common and effective way to treat the cancer.

This study is trying a more focused and faster approach. Instead of treating the whole prostate uniformly, we use very detailed MRI scans to find the exact spots where the cancer is growing most aggressively. Then, we deliver a slightly stronger dose of radiation, called a 'focal boost,' specifically to these areas. Another key difference is how the radiation is given: instead of many small daily doses, this study uses just three larger doses spread out over a single week. This is designed to be more convenient for patients and potentially more effective against the cancer.

The main idea behind this study is to see if this new, more targeted and intense radiotherapy treatment is safe. We want to make sure it doesn't cause more side effects, especially problems with the bladder or bowels, compared to the standard treatment. If it proves safe, it could become a new option that not only reduces the number of hospital visits but also lowers the chance of the cancer coming back.

Key takeaways

New radiotherapy approach for prostate cancer.
Uses detailed MRI scans to target cancer precisely.
Treatment delivered in just three sessions over one week.
Aims to be safer and potentially more effective than current methods.
Includes hormone therapy.
Focuses on checking safety and side effects over one year.

Who may be eligible?

This study is for men aged 18 or older who have prostate cancer that is considered 'intermediate' or 'high-risk' but has not spread beyond the prostate. Your doctor will be able to tell you if your cancer fits these categories based on its type, PSA levels, and other tests.

To join, you would need to have had a specific type of prostate MRI scan within the last year and be planning to receive hormone therapy as part of your treatment. You should also be generally fit enough to take part in the study, which your doctor will assess.

You would not be able to join if your cancer has spread to other parts of your body, or if there's a disagreement between your MRI scan and biopsy results about the cancer's location. Also, if you've already started hormone therapy more than two months ago, or have another active cancer (unless it's a very common, easily treated skin or bladder cancer), you might not be eligible.

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 aged 18 or over?
Do you have prostate cancer that has not spread?
Has your doctor told you your cancer is 'intermediate' or 'high-risk'?
Have you had a 3 Tesla prostate MRI scan in the last year?
Are you planning to have hormone therapy for your prostate cancer?
Are you generally fit enough for treatment (as assessed by your doctor)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the study, you would receive a course of radiotherapy delivered in three sessions on alternating days over one week. This is a shorter treatment compared to standard radiotherapy. You would also receive hormone therapy (triptorelin injections), as planned by your doctor, for a period of up to six months for intermediate-risk cancer or up to 24 months for high-risk cancer. Throughout the study, you would have regular check-ups to monitor your health and any side effects. The study aims to follow participants for at least one year to check for any long-term effects on your bladder and bowel. Your involvement would continue as long as necessary to complete all required follow-up assessments.

Potential risks and benefits

Participating in this study might offer the benefit of a more targeted and quicker radiotherapy treatment, potentially reducing the chance of your cancer returning while lessening the number of hospital visits. However, because this is a new way of delivering treatment, there's a possibility of unexpected side effects, though the study is specifically designed to check if side effects are not worse than standard care. As with any medical treatment, there can be risks, including those associated with radiotherapy itself (like bladder or bowel irritation) and the hormone therapy. You have the right to withdraw from the study at any time without affecting your usual care.

Locations (1)

The Ottawa Hospital Cancer Centre
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is 'focal boost' radiotherapy?

'Focal boost' means giving a slightly stronger dose of radiation exactly where the most aggressive cancer cells are located, guided by detailed scans, rather than treating the whole prostate uniformly.

How is this different from standard radiotherapy?

Standard radiotherapy is often given over several weeks in small daily doses to the whole prostate. This study uses fewer, larger doses over one week and targets specific cancer areas more precisely.

What is 'hormone therapy' and why is it used?

Hormone therapy (triptorelin injection) helps by lowering male hormones that can make prostate cancer grow. It's often used with radiotherapy to make the treatment more effective.

Will this treatment hurt?

Radiotherapy itself is painless, but you might experience side effects like tiredness or bowel/bladder changes, similar to standard radiotherapy. The study aims to check if these side effects are not worse.

How long will I be followed up after treatment?

The study will follow your progress for at least one year after your treatment to monitor your health and any long-term effects.

How to find out more

Scott Grimes

sgrimes@ohri.ca 613-737-7700 Official trial record

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