Open-label clinical phase 1/2 study to assess the safety and efficacy of the SpectraCure P18 System and verteporfin for injection for the treatment of primary localized prostate cancer
This study is looking at a new treatment for prostate cancer that is only in the prostate gland and hasn't spread. The new treatment involves a system called SpectraCure P18 and a drug called Visudyne. The main goal is to check if this treatment is safe and doesn't cause serious side effects, especially to nearby organs like the rectum and bladder. They will also look at how well the treatment destroys cancer cells in the prostate. If it proves safe and effective, this could be a new option for men with this type of prostate cancer. Participants will also receive Ciprofloxacin, an antibiotic, as part of the treatment.
At a glance
What is this study about?
This study is exploring a new treatment for prostate cancer that is still contained within the prostate gland and hasn't spread to other parts of the body. It combines a special light treatment, using the SpectraCure P18 System, with a drug called Visudyne. The idea is that the drug makes cancer cells sensitive to light, and then the light treatment activates the drug to destroy the cancer cells, while trying to protect healthy tissue.
The main aim of the study is to find out if this new treatment is safe. Doctors will be carefully watching for any side effects, especially those that might affect the rectum or bladder, which are close to the prostate. They expect that there should not be any serious damage to these organs or any serious drug-related problems. They will use MRI scans to check for any issues after the treatment. They also want to see how well the treatment actually works to kill cancer cells in the prostate, measuring this with MRI scans and by checking biopsies after 6 months.
This is a Phase 1/2 study, which means it’s still in the earlier stages. Phase 1 focuses heavily on safety, while Phase 2 starts to look more closely at how well the treatment works. If this treatment is shown to be safe and effective in this study, it could offer a new option for men with localised prostate cancer in the future. Participants will also be given Ciprofloxacin, an antibiotic, as part of the study.
Key takeaways
- This study is for men with prostate cancer that hasn't spread.
- It uses a new light-based treatment with a drug called Visudyne.
- The main goals are to check the treatment's safety and how well it removes cancer.
- You'll have MRI scans and biopsies to track progress.
- Participation lasts at least 18 months with follow-up appointments.
- This is an early-stage study, so new risks are still being identified.
Who may be eligible?
To be able to join this study, you must be a man aged 18 or over. There is no upper age limit.
The study is specifically for men who have prostate cancer that is only in the prostate gland itself and has not spread to other parts of the body. You can't have participated in certain other treatments for your prostate before, and your general health needs to be well enough to take part in the study procedures.
There are also other detailed medical checks to make sure the treatment is suitable and safe for you. Your doctor will be able to tell you if you meet all the criteria.
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 18 or older?
- Do you have prostate cancer that is only in the prostate gland and has not spread?
- Are you generally well enough to have the treatment and attend appointments?
- Have you not had certain previous treatments for your prostate cancer?
What does participation involve?
If you join this study, you will receive the new treatment which involves a drug called Visudyne given through a drip, followed by a special light treatment using the SpectraCure P18 System. You will also be given an antibiotic called Ciprofloxacin. After the treatment, you will have follow-up appointments and MRI scans to check how you are doing and how well the treatment worked. This will involve appointments at specific times, including one week after treatment, then at 6 and 18 months, where biopsies will be taken to see if the cancer is gone. The total duration of your participation in the study will be at least 18 months.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is 'localised prostate cancer'?
This means the cancer is only found inside the prostate gland and hasn't spread to other parts of your body.
What is Visudyne and how is it given?
Visudyne is a drug that makes cancer cells sensitive to light. It's usually given as a small injection into your vein.
What does a 'Phase 1/2 study' mean?
This type of study is in the early stages. Phase 1 checks how safe the new treatment is, and Phase 2 starts to see how well it works.
Will I still get my regular cancer care if I join?
Yes, joining a study should not affect your right to receive your usual medical care.
What happens if the treatment causes side effects?
The study team will monitor you very closely for any side effects and will provide care to manage them.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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