A trial looking at a new way of giving photodynamic therapy for prostate cancer (SpectraCure P18)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Phase 1/2
This trial is looking at photodynamic therapy to treat prostate cancer that has come back after radiotherapy. 
 
It is for men whose cancer is inside the prostate gland Open a glossary item and who can’t, or choose not to have surgery.

More about this trial

Prostate cancer that has come back after radiotherapy can be difficult to treat. So, researchers are looking for new treatments.  
 
In this trial, they are looking at photodynamic therapy. It uses a drug and laser light. After you have the drug, doctors activate the light. This kills cancer cells.
 
The type of photodynamic therapy (PDT) they are using in this trial is called interstitial photodynamic therapy. Some with prostate cancer, who haven’t had treatment, have had this. But they had a different drug to the one used in this trial. 
 
To have treatment the doctor puts hollow needles into your prostate gland. This will be done under general anaesthetic Open a glossary item. You then have a drug through a drip. The drug is activated in the prostate by the laser light. They do this through fibres within the needles. The fibres also monitor the levels of the drug and laser light inside the prostate.
 
The system that delivers the light is called the SpectraCure P18 System. The drug you have is called verteporfin. It is a chemical that makes cells sensitive to light. 
 
There are 2 parts to this trial. Part 1 is looking at the best dose of verteporfin to give. Part is testing this dose in more people. 
 
The aims of this trial are to:
  • find the best dose of verteporfin
  • find the best dose of light 
  • see how well treatment works 
  • to see how well the SpectraCure P18 system works
  • learn more about the side effects
Please note- you might not benefit from this treatment. But it may help others with prostate cancer in the future.
 

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
 
You may be able to join this trial if all of the following apply. 
  • You have had external beam radiotherapy, or high dose rate internal radiotherapy (brachytherapy) for cancer inside the prostate gland and it has come back 
  • You aren’t suitable or choose not to have surgery to remove the prostrate  
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1) 
  • You are well enough to carry out all your normal activities apart from heavy physical work 
  • You have satisfactory blood test results
  • Your kidneys and liver work well
Who can’t take part
 
You cannot join this trial if any of these apply. 
 
Cancer related 
You:
  • have cancer that has grown outside the prostate gland or spread elsewhere in the body 
  • have had permanent seed brachytherapy
  • had a Gleason score Open a glossary item of 10 when you were first diagnosed. Your doctor will know this. 
  • have cancer that has grown into a major blood vessel or nearby the area that the light will be directed at 
  • are already having treatment with a photosensitizing drug
  • have taken part in another trial within 3 months before joining this trial 
Medical conditions
You:
  • have a condition called porphyria or any other condition made worse by light or you are taking amiodarione
  • have had any surgery in the last week 
  • have an infection that isn’t getting better
  • have severe side effects from previous treatments that aren’t getting better or moderate inflammation of the back passage (rectum) caused by radiotherapy 
  • have any other medical condition or mental health problem that the trial team think would affect you taking part
Other
You: 
  • can’t have verteporfin
  • are sensitive to verteporfin or any of its ingredients
  • are allergic to substances called porphyrins

Trial design

This is a phase 1/2 trial. The researchers need up to 61 people to take part including about 10 people at the University College Hospital in London.  

This trial is in 2 parts:

  • dose escalation (part 1) 
  • dose expansion (part 2) 

You have interstitial PDT under a general anaesthetic Open a glossary item in the operating theatre. The doctor puts an ultrasound probe into the back passage (rectum). This helps the SpectraCure P18 system to develop a treatment plan based on the size and shape of the prostate. 

The doctor puts some needles into the prostate through the skin between your legs, between the back passage and your scrotum (perineal area). And they put laser fibres inside the needles.

The first few men have a low dose of verteporfin. If they don’t have severe side effects, the next person has a higher dose. And so on, until they find the best dose to give. This the dose escalation part of the study.

The researchers then test the best dose found in more men. This is the dose expansion part. 

You have the verteporfin as a drip into a vein. This is followed by the laser light given via the laser fibres into the prostate. The light is monitored using the same fibres. 

The procedure takes up to 4 hours. You have a tube put into your bladder afterwards to drain the urine (urinary catheter). This stays in until you go home. You stay overnight in hospital after having PDT. 

Quality of life
The trial team will ask you to fill out some questionnaires before you start treatment and afterwards. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
 

Hospital visits

You see a doctor and have some tests before you can take part. These include:
  • physical examination
  • blood samples
  • MRI scan
You have a check up and blood tests at:
  • 1 week
  • 2 weeks
  • 1 month
  • 3 months
  • 6 months
  • 9 months (only if you join part 2)
  • 12 months
You have an MRI:
  • 5 to 9 days after treatment
  • at 6 months (only if you join part)
  • at 1 year
You give a sample of tissue Open a glossary item from the prostate at 6 months and 12 months.
 

Side effects

This is the first time men with prostate cancer that has come back after radiotherapy are having interstitial PDT using the SpectraCure P18 system. So, there may be some side effects we don’t know about yet. 
 
The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The possible side effects of interstitial PDT are:
  • skin sensitivity to light
  • pain around the prostate gland
  • problems passing urine for a short time
  • leaking urine
  • infections
  • a reaction to the drug
  • narrowing or scarring of the tube that carries urine from the bladder to outside the body (urethra)
The most common side effects of verteporfin are:
  • fainting or feeling light headed
  • headache
  • breathlessness
  • feeling sick
  • tiredness
  • a reaction to the drip (infusion)
  • high levels of cholesterol in the body
Your skin and eyes will be sensitive to light after the procedure. You should avoid direct sunlight and bright lights for 5 days. You should cover up to protect your skin and wear dark sunglasses to protect your eyes.
 

Location

London

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Caroline Moore

Supported by

SpectraCure 

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16323

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Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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