A trial looking at stereotactic body radiotherapy for prostate cancer (PACE-NODES)
Cancer type:
Status:
Phase:
This trial is comparing stereotactic body radiotherapy to the prostate with stereotactic body radiotherapy to the prostate and lymph nodes in the 
.
It is open to people with prostate cancer that has a high risk of the cancer coming back.
More about this trial
Your prostate cancer might have a high risk of coming back if there are very small areas of cancer in the surrounding the prostate. These may only be a few cancer cells and so cannot be detected on a scan.
External beam radiotherapy is a common treatment for prostate cancer. One type of external beam radiotherapy is called stereotactic body radiotherapy. This is also known as SBRT, SABR or SRT. Stereotactic body radiotherapy aims the beams of radiotherapy at the cancer. This gives a high dose of radiotherapy to the cancer. And the normal tissue around the cancer receives a lesser dose. We know from research that SBRT is safe to treat people with prostate cancer.
In this trial, researchers are looking at giving SBRT to the prostate cancer and to the lymph nodes in the pelvis. They want to find out whether having SBRT to the lymph nodes as well, can help stop the cancer coming back. So, half the people in this trial will have SBRT to the prostate only. The other half will have SBRT to the prostate and the nearby lymph nodes.
The aims of this trial are to find out:
- whether having SBRT to the prostate and lymph nodes is better than having SBRT to the prostate only, to help stop the cancer coming back
- more about the side effects of having SBRT to the prostate and lymph nodes
- how having SBRT to the prostate and lymph nodes affects
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 you have high risk prostate cancer. High risk prostate cancer is prostate cancer that has one or more of the following.
- You have a
Gleason score of 8 to 10 (grade 4 or 5). - You have cancer that has broken through the capsule (covering) of the prostate and might have spread to the nearby organs such as the back passage, bladder or pelvic wall (stage T3a, T3b or T4).
- You have a
PSA level of more than 20ng/ml. For people taking 5 alpha reductase inhibitors such as finasteride, it is a PSA level of greater than 10ng/ml.
And all of the following apply. You:
- are planned to have between 1 and 3 years of hormone treatment
- have had a multiparametric MRI scan or biparametric MRI scan. Your doctor will know about this.
- have had a scan such as
bone scan , CT scan , MRI scan or PET-CT scan that shows your cancer has not spread to another part of the body. Your doctor will know if you have. - are able to look after yourself, be up for half the day but might not be able to work (performance status 0, 1 or 2)
- are willing to use reliable contraception during treatment and for a year after if there is any chance your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- are known to have cancer in the lymph nodes near the prostate. Your doctor will know this.
- have cancer that has spread outside the pelvis to another part of the body. Your doctor will know this.
- have a PSA level that is more than 50ng/ml. For people taking 5 alpha reductase inhibitors, it is more than 25ng/ml. This is unless you have had a scan that shows the prostate cancer has not spread to the nearby lymph nodes or to another part of the body outside the pelvis. Your doctor will be able to tell you about this.
- have had previous surgery, radiotherapy, chemotherapy or hormone treatment for prostate cancer
- have implants, such as both hips replaced, or other reasons that would make it more difficult to plan treatment to the lymph nodes in the pelvis
- have had chemotherapy within 6 weeks of starting radiotherapy
Your doctor might put gold markers (fiducial markers) into the prostate. You may not be able to take part if are not able to have the gold markers put into the prostate. This includes having a problem with how the blood clots. If you are taking medication to stop the blood clotting, you must be able to stop the medication to have the markers put in. Talk to your doctor about this.
Trial design
This is a phase 3 trial. The team want 1,128 people to take part.
It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you are in. The 2 groups are:
- stereotactic body radiotherapy to the prostate
- stereotactic body radiotherapy to the prostate and the lymph nodes in the pelvis
In both groups you have 5 treatments of radiotherapy. This is on alternative days over 2 weeks.
You start your hormone treatment before starting radiotherapy. You continue taking it during radiotherapy and after. This is .
Quality of life
You fill in questionnaires before starting treatment and then after treatment at:
- 4 weeks
- 6 months
- 1 year and then
- every year up to 5 years
The questions ask about:
- your general health and wellbeing
- your daily activities
- side effects
These are quality of life questionnaires.
You do not have to agree to do these questionnaires. You can still take part in the trial.
Tissue samples for research
The team will ask for a piece of the prostate tissue sample () that was taken to diagnose your cancer. The piece of tissue is anonymised so you will not be able to be identified. And it is stored in a safe and secure place.
The tissue will be available for future researchers to use.
You don’t have to agree to this. You can still take part in the trial.
Hospital visits
You see the doctor before taking part to have tests. These tests include:
- a p
hysical examination - PSA blood test
- MRI scan of the pelvis
- another scan such as a bone scan, CT scan or PET-CT scan. Your doctor will tell you which one you will have.
You see the doctor when you finish your radiotherapy. This is to see how you are and to ask about any side effects.
Follow up
After treatment you see the doctor at:
- 2 weeks
- 4 weeks
- 8 weeks
- 12 weeks
- every 6 months to 2 years
- every year to 5 years
You have a PSA blood test done at 6 months and then every 6 months up to 5 years.
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 most common side effects of radiotherapy to the prostate are:
- tiredness
- problems passing urine including wanting to go more frequently and urgently
- diarrhoea
- discomfort in the back passage
- discomfort passing urine
We have more information about radiotherapy to the prostate and its side effects.
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 Nicholas Van As
Supported by
Institute of Cancer Research (ICR)
National Institute for Health Research Clinical Research Network (NIHR CRN)
Prostate Cancer UK
The Radiotherapy Trials Quality Assurance (RTTQA) Group
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
