Radium-223: evaluation of activity and surrogate response
| ISRCTN | ISRCTN17805587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17805587 |
| Clinical Trials Information System (CTIS) | 2013-004055-20 |
| Protocol serial number | 17391 |
| Sponsors | Royal Marsden NHS Foundation Trust, The Institute for Cancer Research |
| Funder | Bayer Pharmaceuticals Plc (UK) |
- Submission date
- 21/01/2015
- Registration date
- 21/01/2015
- Last edited
- 04/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Dalia Ismail
Scientific
Scientific
The Institute for Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase II randomised trial of biomarkers to assess (dose) response in patients with metastatic castration resistant prostate cancer treated with radium-223 |
| Study acronym | REASURE |
| Study objectives | The aim of this trial is to identify potential markers of response to treatment with radium-223 in patients with castration-resistant prostate cancer with bone metastases. |
| Ethics approval(s) | London Surrey Borders, 23/09/2014, ref: 14/LO/1385 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Patients will be randomised to receive either 50kBq/kg or 80kBq/kg of radium 223. Patients in both arms will receive radium-223 every 4 weeks for up to 6 treatments. Follow up will be from 4 weeks after the last administration of radium-223. Patients will be evaluated every four months until 1 year after last administration. |
| Intervention type | Other |
| Primary outcome measure(s) |
The proportion of patients showing bone metastases response on diffusion weighted MRI (DW-MRI). From pre-treatment to any point after 1st injection and the end of cycle 6 will be used to define response. |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 01/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 38 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Histologically or cytologically confirmed adenocarcinoma of the prostate. 2. Known castration resistant disease defined as: 2.1. Castrate serum testosterone level: = 50 ng/dL (2.0nM) 2.2. Bilateral orchidectomy or on maintenance androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study 2.3. Serum PSA progression defined by PCWG II criteria (i.e. two consecutive increases in PSA over a previous reference value, each measurement taken at least 1 week apart) 3. Serum PSA value = 2 ng/mL 4. Available ALP result from a blood sample taken within previous 8 weeks 5. Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within previous 12 weeks 6. Age =16 years 7. ECOG performance status 0-2. 8. Life expectancy = 6 months. 9. No prior chemotherapy for CRPC (adjuvant chemotherapy for hormone naïve disease is permissible). 10. Adequate laboratory requirements: 10.1.Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L 10.2. Platelet count greater than or equal to 100 x109/L 10.3. Haemoglobin greater than or equal to 10.0 g/dL (100 g/L; 6.2 mmol/L) 10.4. Total bilirubin level less than or equal to 1.5 institutional upper limit of normal (ULN) 10.5. ASAT and ALAT less than or equal to 2.5 x ULN 10.6. Creatinine less than or equal to 1.5 x ULN 10.7. Albumin greater than 30 g/L 11. Willing and able to comply with the protocol, including all assessments, scans, procedures, followup visits and examinations 12. Must be fully informed about the study and has signed the informed consent form |
| Key exclusion criteria | 1. Any prior radioisotope therapy 2. Surgery, radiation, chemotherapy, or other anticancer therapy within four weeks prior to randomisation into the study with the exception of LHRH agonists 3. Intention to commence cytotoxic chemotherapy within six months 4. Prior other malignancy within three years. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed 5. Treatment with any investigational drug within 30 days prior to randomisation into the study 6. History of visceral metastasis, or visceral metastases, as assessed by chest/abdominal/pelvic CT within previous 8 weeks 7. Malignant lymphadenopathy exceeding 1.5 cm in short-axis diameter 8. Known brain or leptomeningeal involvement 9. Imminent/established spinal cord compression based on clinical findings/MRI (can be re-screened following appropriate treatment) 10. Blood transfusion or erythropoietin stimulating agents within the four weeks prior to randomisation 11. Faecal incontinence 12. Unsuitable for MRI (patient refusal or clinical contra-indication) 13. Inadequate organ or bone marrow function 14. Any other serious illness or medical condition |
| Date of first enrolment | 30/01/2015 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Institute for Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Sutton
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from reasure-icrctsu@icr.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Fracture risk | 01/04/2021 | 07/05/2021 | Yes | No |
| Results article | Disease response in bone | 03/10/2023 | 04/10/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/10/2023: Publication reference added.
07/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
22/06/2017: Publication and dissemination plan and IPD sharing statement added.
10/05/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/05/2016 to 30/06/2017.
2. The overall trial end date was changed from 14/05/2016 to 01/12/2018.
