A trial looking at partial ablation treatment for prostate cancer (PART)
Cancer type:
Status:
Phase:
This trial is comparing partial ablation treatment with radical treatment for prostate cancer. Radical treatment includes:
It is open to people who have intermediate risk prostate cancer in only 1 side of their prostate.
More about this trial
The 
has 2 sides (lobes). You can get cancer in both sides or in only 1 side.
Radical treatment treats the whole prostate regardless of where the cancer is. Partial ablation treats only the side of the prostate where the cancer is and not the whole prostate.
All treatments can cause side effects. Researchers think that only treating the side of the prostate that has cancer in it could reduce the side effects. Or it could make the side effects less severe.
In this trial researchers are looking at 2 types of partial ablation treatment. They are:
- high intensity focused ultrasound (HIFU)
- irreversible electroporation (IRE). IRE is also called NanoKnife.
Doctors already treat some prostate cancers with HIFU or IRE in certain situations.
HIFU uses sound waves to heat up the cancer cells and this destroys them. IRE uses pulses of electricity to make holes in the wall of the tissue (membranes) surrounding each of the cancer cells. And this destroys the cancer cells. The side effects of HIFU and IRE might not be as bad as those for radical treatment.
The aims of the trial are to find out:
- how well IRE and HIFU works when compared to radical treatment
- more about the side effects of the treatments
- how these treatments affect
quality of life
Who can enter
The following bullet points are a summary of 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 medium (intermediate) risk prostate cancer in 1 side (lobe) of the prostate. You might be able to join if you have cancer in both sides of the prostate. That is if the main cancer is medium risk cancer and in only 1 side of prostate, and on the other side it is low risk prostate cancer.
- have a Gleason score of 7 (group grade 2 or 3)
- have a
PSA level that is 20 ng/ml or less within the past 4 months - are fit enough to have the standard treatment for prostate cancer and at least 1 of the trial treatments. Your doctor will talk to you about this.
- have had an mpMRI scan before having tissue samples (
biopsies ) taken from both sides of the prostate within 6 months of agreeing to join the PART trial - are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have already had or are having active treatment for your prostate cancer
- had surgery to the prostate such as a transurethral prostatectomy (TURP) or had implants put into the prostate
- are not able to have a transrectal ultrasound (TRUS)
- have cancer that has spread to the outside of the prostate or has spread to another part of the body
- have intermediate risk cancer in both lobes of the prostate or the risk is higher. You have only low risk prostate cancer (Gleason grade 1) or you have high risk cancer (Gleason grade 4 and above).
- have had active treatment for another cancer in the past 3 years apart from
non melanoma skin cancer - are to have more than 6 months of hormone therapy
- are taking part in another clinical trial that is looking at a treatment for prostate cancer or have taken part within the past 4 months
Medical conditions
You cannot join this trial if any of these apply. You:
- are not able to have a
general anaesthetic - have had a problem with not being able to pass urine (urinary retention) within the past 6 months
- have had narrowing of the tube that that takes urine from the bladder to the outside (urethral retention) or you have had a tube (stent) or metal implants put in to widen the urethra
- have large
cysts in the prostate or you have areas of calcium in the prostate - have an active inflammatory bowel disease that affects the back passage (rectum)
- have had major surgery to the rectum apart from surgery to remove haemorrhoids
- are at an increased risk of developing an abnormal hole (fistula) between the rectum and the tube that drains urine from the bladder (urethra). Your doctor will know if you are at risk of this happening.
- are unable to have a mpMRI scan
- have had one or both hips replaced
- have an electronic device such as a pacemaker in your body
- aren’t able to or are unwilling to have a tube (catheter) put into the bladder
- have a problem with bleeding. You are taking medication such as warfarin to thin the blood unless you are able to stop taking it for a short time. Talk to your doctor about this.
Other
You cannot join this trial if any of the following apply. You:
- are allergic or very sensitive to medications used to relax the muscles
- have a medical condition that means you cannot have medications to relax the muscles
- want to be able to have children after the treatment
Trial design
This is a phase 3 trial. The team need 800 men to take part.
There are 2 parts to the trial. The main trial and the information study.
The main trial is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:
- partial ablation
- radical treatment
For either group your treatment should start around 6 to 8 weeks after and within a year of randomisation.
Partial ablation
There are 2 types of treatment you can have. They are:
- high intensity focused ultrasound (HIFU)
- irreversible electroporation (IRE)
Your healthcare team will use certain features of your cancer such as size and where it is to work out which is the best form of partial ablation treatment for you.
These treatments are not available in all hospitals. So you may need to travel to another hospital for your treatment. Your doctor will talk to you about this.
HIFU
HIFU uses heat to destroy the areas of cancer. After the treatment you can usually go home the same day but you might need to stay in hospital for one night.
To have HIFU you have a general anaesthetic. You also have a tube (catheter) put into your bladder.
You are asleep during the treatment. For the treatment the doctor puts a probe into your back passage (rectum). The probe produces ultrahigh frequency sound waves that target the cancer areas and heat them up. The treatment takes about 1 to 2 hours.
The catheter stays in your bladder for at least 2 days. You might need to keep it in for up to a week.
You should be able to return to your normal activities within 2 to 3 weeks after treatment.
IRE
IRE uses an electrical current to destroy the cancer. After the treatment you can usually go home the same day but you might need to stay in hospital for one night.
To have IRE you have a general anaesthetic. You also have a tube (catheter) put into your bladder.
You are asleep during the treatment. For the treatment you have small thin probes, like needles, put into your skin in the area between the back passage and scrotum (the perineum). The doctor uses an to guide them to where to put the probes.
IRE uses electrical pulses along the probes to create tiny holes in the wall of the tissue (membrane) surrounding each cancer cell. This then destroys the cancer cells. The treatment takes about 1 to 1½ hours.
The catheter stays in your bladder for at least 2 days. You might need to have it for up to a week.
You should be able to return to your normal activities within 2 to 3 weeks after treatment.
Radical treatment
Radical treatment treats the whole prostate. This can be either:
Your doctor will tell you about these treatments. And then both of you can decide which is best for you.
Information study
The team will ask to record the conversation you have with your doctor about the PART trial.
They will also ask around 20 men to take part in an interview. This can be in person, online or over the phone and will take about 30 minutes. This is to discuss your experiences in more detail.
The team want to understand:
- how doctors talk to their patients about the PART trial
- why people decide whether to take part or not
You don’t have to take part in the information study if you don’t want to. You can still take part in the trial.
Quality of life
You fill in some questionnaires before starting treatment and then after treatment at:
- 6 weeks
- 3 months
- 6 months
- 1 year
- 2 years
- 3 years
The questions ask about:
- your general health
- side effects
- what daily activities you can do
These are quality of life questionnaires.
Hospital visits
You see the doctor for a and blood tests before taking part.
Everyone
You see the doctor regularly during treatment to see how you are.
After treatment you see the doctor to see how you are and for blood tests at:
- 6 weeks
- 3 months
- 6 months
- 9 months
- 1 year
- 2 years
- 3 years
HIFU and IRE
If you have HIFU or IRE you have a mpMRI scan after treatment at:
- 1 week
- 1 year
- 3 years
You also have tissue samples () of the prostate at:
- 1 year
- 3 years
Radical treatment
Those who have radical treatment have scans and biopsies done only if their doctor asks for them.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The side effects of irreversible electroporation (IRE) include:
- bruising where the needles go into the prostate
- problems passing urine, not being able to pass urine, blood in the urine, passing urine more often, needing to pass urine urgently, not being able to control passing urine and urinary infections
- sexual problems especially not been able to get or maintain an erection
- discomfort, pain and bleeding after treatment
- side effects of having a general anaesthetic such as feeling or being sick, dizziness, feeling faint, itching, headaches, aches and pain
The side effects of high intensity focused ultrasound (HIFU) include:
- problems passing urine, not being able to pass urine, blood in the urine, passing urine more often, needing to pass urine urgently, not being able to control passing urine and urinary infections
- sexual problems especially not been able to get or maintain an erection
- discomfort, pain and bleeding after treatment
- side effects of having a general anaesthetic such as feeling or being sick, dizziness, feeling faint, itching, headaches, aches and pain
We have more information about HIFU for prostate cancer.
We have information about the other treatments for prostate cancer and their possible side effects:
Your doctor will talk to you about the side effects of all the treatments and answer any questions you have before you agree to take part.
Location
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.
Chief Investigator
Professor Richard J Bryant
Supported by
University of Oxford
National Institute for Health Research (NIHR)
University of Bristol (Qualitative Research Integrated within Trials (QuinteT); the Information Study)
AngioDynamics
EDAP-TMS
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
