RecruitingPHASE1, PHASE2INTERVENTIONAL

Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

This study is looking into a new way to treat prostate cancer that has returned after initial treatment. It focuses on men whose cancer has come back locally, meaning in or near the prostate gland. The treatment involves a special system called SpectraCure P18, which uses light, combined with a drug called verteporfin. Researchers want to understand if this new treatment is safe for patients and how well it works. They are also trying to find the best dose of the treatment to make it effective. Currently, options for recurrent prostate cancer can be quite limited, so finding new methods is very important for patients. This study is in its early stages (Phase 1 and 2), which means it's one of the first times this treatment is being tested in humans.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

SpectraCure AB

Enrolment target

Start

21 Mar 2017

Estimated completion

31 Dec 2027

Recurrent Prostate Cancer

What is this study about?

Prostate cancer is a very common cancer affecting men. While many men are successfully treated, for some, the cancer can return later on. When prostate cancer comes back, especially if it's still located in the prostate area, treatment options can sometimes be more challenging than for the first diagnosis. Currently, treatments for recurrent prostate cancer can include more radiation, surgery if you previously had radiation, or hormone therapy.

This study is exploring a new treatment approach called the SpectraCure P18 System, which uses advanced light technology, along with a medication called verteporfin. The main goal is to find out if this combination is safe for men with recurrent prostate cancer and if it can effectively treat the cancer. They are also trying to figure out the best way to give this treatment for the best results. Your doctors carefully monitor your PSA levels after prostate cancer treatment, and if these levels rise, it can indicate the cancer has returned.

Finding new and effective treatments for recurrent prostate cancer is really important. This study offers a chance to be part of research into promising new options for managing your condition. It's an early-stage study, meaning doctors are carefully watching how it works before it can be used more widely.

Key takeaways

This study evaluates a new light-based treatment for prostate cancer that has returned.
It combines a special light system (SpectraCure P18) with a light-activated drug (verteporfin).
It's for men whose prostate cancer has come back locally after previous radiation therapy.
The main goals are to check treatment safety and effectiveness.
Participation involves regular hospital visits for treatment and monitoring.
You can stop participating at any time without affecting your standard care.

Who may be eligible?

This study is for men over 18 whose prostate cancer has come back only in the prostate area, or very close to it. You would have already had prostate cancer treatment with radiation (either external beams or internal seeds), and your doctors would have confirmed that the cancer has returned locally. Your prostate gland should also be a certain size, and you should not be suitable for surgery or other curative radiation treatments at this point.

To be considered, you also need to be generally well enough to take part. This means having a good level of physical activity, an expected lifespan of at least 8 months, and your blood tests for things like blood count, kidney, and liver function need to be within healthy ranges. You must also be able to understand the study and agree to participate by signing a consent form.

There are some reasons why you wouldn't be able to join. For instance, if your cancer has spread to other parts of your body, or if you had a specific type of radiation called seed implantation (brachytherapy) for your initial treatment. Also, if you have certain other serious medical conditions, a severe infection, or a known allergy to the study medication or similar drugs, you would not be eligible. If you've recently had major surgery or are taking other medications that make you more sensitive to light, you also can't take part.

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 over 18 years old?
Has your prostate cancer come back only in the prostate area after radiation treatment?
Are you generally feeling well and able to be active?
Are your blood tests (like blood count, kidney, and liver function) within healthy ranges?
Have you *not* had brachytherapy (seed implants) as your initial prostate cancer treatment?
Do you *not* have cancer spread to other parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the experimental treatment which involves a special light system and the verteporfin drug. The study team will explain the exact procedure in detail. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how your body is responding to the treatment. These visits will help the doctors assess the safety and effectiveness of the new treatment. The total number of visits and the overall duration of your participation will be fully explained by the study team, but typically, early-stage studies like this involve close monitoring over several months or longer. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment that isn't widely available yet, which could help manage your recurrent prostate cancer. However, as with any new treatment, there are also potential risks, including side effects from the medication or the light treatment. These will be fully explained to you before you agree to take part. It's important to remember that new treatments aren't always effective for everyone, and there's no guarantee of benefit. You have complete flexibility and the right to withdraw from the study at any point without needing to give a reason, and this decision will not affect your ongoing medical care.

Locations (4)

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

Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
Skåne University Hospital
Verified postcode
Malmö, Sweden· Recruiting
Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is prostate cancer recurrence?

Prostate cancer recurrence means the cancer has come back after you've already had treatment for it.

What is verteporfin?

Verteporfin is a drug that makes certain cells, including cancer cells, sensitive to light when activated by a specific type of light.

What does 'Phase 1/2' mean?

This means it's an early-stage study, checking the safety of the treatment and looking for initial signs of whether it works, and figuring out the best dose.

Will this treatment cure my cancer?

This study is investigating if the treatment is safe and effective. There is no guarantee of a cure, but it aims to control the cancer.

Will I have to travel for the study?

Yes, you would need to attend appointments at the specific study hospital or clinic where the treatment is offered.

How to find out more

Johannes Swartling

jsw@spectracure.com +46 (0) 46 16 20 70 Official trial record

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