REASURE (Radium-223: Evaluation of Activity and SUrrogate REsponse)
Research type
Research Study
Full title
A phase II randomised trial of biomarkers to assess (dose-) response in patients with metastatic castration resistant prostate cancer treated with radium-223.
IRAS ID
134143
Contact name
Christopher Parker
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2013-004055-20
Duration of Study in the UK
2 years, 6 months, 4 days
Research summary
Around 10,000 men die from castration-resistant prostate cancer (CRPC) in the UK each year. In more than 90% of patients with CRPC, the cancer eventually spreads to the bones (called bone metastases). Individuals with bone metastases may experience skeletal-related events (SREs) such as spinal cord compression or fractures. They may also suffer reduced quality of life and shorter survival. Current bone-targeted therapies for patients with CRPC are limited to delaying skeletal events with no improvement in survival or quality of life.
Radium-223 is a new type of internal radiotherapy treatment, which uses a form of radiation called alpha particles to kill cancer cells. Radium-223 is very good at targeting bone cancer cells without causing much damage to healthy bone. This treatment produces fewer side effects than some other types of radiotherapy. Previous studies of radium-223 have shown that it can delay SREs and also improve quality of life and overall survival.
There is now a need for further studies to optimise the use of radium-223. It is particularly important to find surrogate markers that predict response to radium-223 at an early stage. Such information could be used in future research to determine the best way to use radium-223.
In this study we want to look at a range of possible markers including different imaging (scanning) techniques - diffusion-weighted MRI and PET/CT - as well as biomarkers that are found in the blood and urine. The main research question is: can response to radium-223 be reliably measured by imaging techniques and/or circulating biomarkers.
This study will randomise 38 patients with CRPC and bone metastases to receive one of two doses of radium-223 (either 55kBq/kg or 88kBq/kg radium-223) every 28 days for 6 treatments. Patients will be followed up for one year after treatment.
Lay Summary of Results
Is Whole Body MRI an effective way to assess disease progression and response in patients with prostate cancer that has spread to the bones?
Results of the REASURE trial: Radium-223 in metastatic castration resistant prostate cancer: whole body diffusion-weighted MRI to assess response, a phase II randomised trial to assess disease response to radium-223
We have provided these results to you as several years ago, you volunteered to take part in the REASURE trial as part of your treatment for prostate cancer. We would like to thank you for participating and share how your participation has helped to improve knowledge.
Who carried out the study?
The REASURE trial was funded by Bayer, which provided the study drug, Radium 223. The Chief Investigator is Professor Chris Parker of The Royal Marsden Hospital NHS Foundation Trust and The Institute of Cancer Research. REASURE is coordinated by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU).What was the aim of the study?
The REASURE trial was for patients who had had treatment for prostate cancer and whose cancer had spread to the bone.
The main aims of the REASURE trial were to:
• Find the best way to see how well radium 223 is working for each individual patient
• Look at scans and for substances in the blood (biomarkers) that may show how well radium 223 is workingWhy was the research needed?
Doctors usually treat advanced prostate cancer with hormone therapy and chemotherapy. These can work well for a period of time, but the cancer can start to grow again, and often spreads to the bone. Radium 223 is a form of internal radiotherapy used to deliver a strong dose of radiation to the cancerous bone cells, whilst minimising side effects. In this study, researchers wanted to explore the effects of 2 different doses of radium 223, 55kBq/Kg and 88 kBq/Kg. (Bq stands for Becquerel, the unit of measurement used for radiation).
The traditional imaging techniques used to monitor patients are not very accurate for measuring disease progression or response in cancer that has spread to the bone, and new ways to measure the effect of treatments are needed, such as MRI scans or blood biomarkers. Researchers were particularly interested to see if a newer imaging technique called whole-body MRI with diffusion-weighted imaging (WBMRI) would be better at monitoring the cancer and the effects of treatment.Who participated in the study and what treatment did they receive?
Between July 2015 and June 2017, 39 men volunteered to take part from 4 UK sites. 36 patients met all the protocol criteria required to start radium 223 treatment in the study.What happened during the study?
Participants received radium 223 via an injection into a vein, every four weeks for up to 6 cycles. 19 patients were allocated to receive the lower dose of radium 223 (55kBq/Kg) and 17 to receive the higher dose (88 kBq/Kg). The effect of the treatment on the cancer was measured at regular intervals with whole-body MRI, normal CT and bone scans as well as blood tests.What did the study show?
Researchers at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research have analysed the data collected during the study.
• For 14 out of 36 patients, the whole-body MRI showed the cancer had responded to the radium 223 treatment; on average these patients lived for 31 months after entering the study.
• For the 22 out of 36 patients with whole-body MRIs that did not show a response, the average survival was 17 months.
• The re were indications that the higher dose of radium 223 was more effective than the lower dose, as more sites of disease (.39 out of 59, 66%) responded to treatment in the higher dose than in the lower dose (34 out of 75, 45%).
• There was a high level of variation in how well the treatment worked between patients and between different bone metastases within individual patients, with some metastatic sites of disease reducing (“responding") whilst new ones appeared during treatment.What do these results mean?
WB MRI is a useful tool for measuring disease evolution and response in patients with bone metastases. The results of the REASURE trial also provide more information about the way radium 223 treatment works. It uncovers the variation in response between patients and between individual bone metastases. Further research is need to understand the reasons for these variations and identify biomarkers which may indicate which patients are most likely to benefit from treatment with radium 223.Where can you learn more about this study?
You can read more about the REASURE study in the medical journal JNCI Cancer Spectrum (where the full results are available).
JNCI Cancer Spectrum articleIf you have any additional questions about the results from the REASURE study, please discuss this information sheet with your local cancer doctor or a member of their team who will be happy to help you.
Local Consultant name and contact details to be inserted here
Local Research nurse and contact details to be inserted hereYour involvement with the REASURE trial has helped to increase the knowledge on prostate cancer and treatments, and we would like to thank you sincerely for taking part and sharing your data with us.
Would you like to help influence cancer research in the future?
We are recruiting trial participants to become patient advocates to help us to develop and deliver our research. You can find out more about our work at the Institute of Cancer Research Clinical Trials and Statistics Unit on our website:https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.icr.ac.uk%2Four-research%2Fcentres-and-collaborations%2Fcentres-at-the-icr%2Fclinical-trials-and-statistics-unit&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C71161319cd914dbd51f108dcdc8962f1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627729833318422%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=4XyYMS0hKu9U85KeZ6MLt7uBXzYZIm55%2FflaVm6gUmw%3D&reserved=0If you would like to help us, then please contact us via email on ppi-icrctsu@icr.ac.uk and we will send you further details.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Results are currently being entered on EudraCT and will be completed by 06/10/2024
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdoi.org%252F10.1093%252Fjncics%252Fpkad077%2FNBTI%2Ffju4AQ%2FAQ%2F7163d358-e2f1-4583-8182-d84674761b24%2F2%2FMb8hHU-6Hz&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C71161319cd914dbd51f108dcdc8962f1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627729833352164%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=9zWJaqNi56p2OHhJCfVYazRk5ApE4NK7VmXSS0UeKuI%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: The lay summary of results has been provided to participating sites for dissemination to participants. Given the time elasped, a significant number of patietns willl be deceased, and the dissemination will be done at the investigators' discreation.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: The data sharing policy for the Institute of Cancer Research Clinical Trials and Statistical Unit is: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.icr.ac.uk%252Four-research%252Fcentres-and-collaborations%252Fcentres-at-the-icr%252Fclinical-trials-and-statistics-unit%252Fworking-with-us%252Fdata-sharing%2FNBTI%2Ffju4AQ%2FAQ%2F7163d358-e2f1-4583-8182-d84674761b24%2F3%2Fz65fSYOp2o&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C71161319cd914dbd51f108dcdc8962f1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627729833377667%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=TtqFYfl0mqRsqzRjCBrdTQMaRBTP25NgUgWAjCTVFs0%3D&reserved=0
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: Yes
If yes, describe or provide a URL: The data sharing policy for the Institute of Cancer Research Clinical Trials and Statistical Unit is: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.icr.ac.uk%252Four-research%252Fcentres-and-collaborations%252Fcentres-at-the-icr%252Fclinical-trials-and-statistics-unit%252Fworking-with-us%252Fdata-sharing%2FNBTI%2Ffju4AQ%2FAQ%2F7163d358-e2f1-4583-8182-d84674761b24%2F3%2Fz65fSYOp2o&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C71161319cd914dbd51f108dcdc8962f1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627729833398852%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mGZig5wSXEGHZ0X6wgfUKkwWc4HBmEWGW915gdjx1b0%3D&reserved=0
If no, explain why:
Submitted on: 24/09/2024REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1385
Date of REC Opinion
23 Sep 2014
REC opinion
Further Information Favourable Opinion