A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
This study is investigating a new treatment for men with prostate cancer that is considered 'intermediate risk.' This means the cancer is not the most aggressive, but still needs treatment. The new treatment, called Irreversible Electroporation (IRE) or NanoKnife, uses carefully controlled electrical pulses to destroy cancer cells in the prostate, without needing major surgery or radiation that can have strong side effects. The main goals are to see if the NanoKnife treatment is good at killing the cancer cells and if it causes any significant side effects. Participants will have the treatment and then be observed for 12 months to check its effects.
At a glance
What is this study about?
When prostate cancer is found, doctors grade it to understand how quickly it might grow. This study is for men with what's called 'intermediate-risk' prostate cancer. For this group, standard treatments like surgery or radiation can often lead to side effects that affect their daily lives, such as issues with urination or sexual function. This study is exploring a new, less invasive approach.
The new treatment being tested is called Irreversible Electroporation (IRE), often known as NanoKnife. Instead of removing the prostate or using radiation, NanoKnife uses very brief, strong electrical pulses to destroy the cancer cells from the inside, leaving healthy tissue mostly unharmed. This method aims to target only the cancerous parts of the prostate, potentially reducing the impact on nearby important nerves and structures, which could mean fewer side effects.
The researchers want to see two main things: first, how well NanoKnife can actually destroy the prostate cancer cells, effectively treating the disease. Second, and equally important, they want to understand if the treatment is safe and if it causes any significant or unexpected side effects. By focusing on intermediate-risk patients, they hope to find a gentler yet effective treatment option for many men.
Key takeaways
- Tests a new prostate cancer treatment called NanoKnife.
- Aims to reduce side effects compared to traditional treatments.
- For men with intermediate-risk prostate cancer.
- Involves treatment under general anaesthesia.
- Requires 12 months of follow-up appointments and checks.
Who may be eligible?
This study is looking for men at least 50 years old with intermediate-risk prostate cancer. You should expect to live at least another 10 years, and your cancer must be contained within the prostate, not spread outside it. Your PSA level (a blood test for prostate health) should be 15 ng/mL or lower, or meet specific criteria if it's slightly higher. Your cancer must have a specific 'Gleason score' of 3+4 or 4+3, which helps classify its aggressiveness.
There are also some things that would mean you can't join. For example, if you're allergic to certain anaesthetic drugs, have an active urine infection, or a history of certain bladder problems. You also can't be interested in having children in the future, or have had other major illnesses or cancers treated recently (within the last 3 years), unless it was a very minor skin cancer. You must also be well enough for anaesthesia and commit to attending all follow-up appointments.
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 a man aged 50 or over?
- Do you have intermediate-risk prostate cancer?
- Is your cancer contained within your prostate (not spread)?
- Are you able to attend all follow-up appointments for a year?
- Do you have a life expectancy of at least 10 years?
What does participation involve?
If you decide to take part, you'll first have a screening visit to make sure you fit all the study requirements. This might include checking recent biopsy results and MRI scans. If you qualify, you'll be scheduled for the NanoKnife treatment. This procedure will take place under general anaesthesia (meaning you'll be asleep) and doctors will use ultrasound to guide them.
After your treatment, you'll have several follow-up appointments over the next 12 months. These are scheduled at 1, 3, 6, 9, and 12 months after the procedure. During these visits, doctors will check how you're recovering and how effective the treatment has been. At the 12-month mark, you'll have another prostate biopsy and an MRI scan to get a full picture of the treatment's success. Your total involvement in the study will be for 12 months.
Potential risks and benefits
Locations (1)
- Princess Margaret Cancer CentreVerified postcodeToronto, Canada· Recruiting
Common questions
What is 'intermediate-risk prostate cancer'?
This means your prostate cancer is not the most aggressive, but it's not low-risk either. It's often treated to prevent it from growing or spreading.
What is NanoKnife treatment?
NanoKnife is a new way to treat prostate cancer using controlled electrical pulses to destroy cancer cells, aiming to be gentler than traditional surgery or radiation.
Will I be put to sleep for the treatment?
Yes, the NanoKnife procedure is done under general anaesthesia, so you will be asleep during the treatment.
How long will I be involved in the study?
You'll be involved for about 12 months, including the treatment and follow-up appointments.
What if I change my mind about participating?
You are free to leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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