Radium-223: evaluation of activity and surrogate response

ISRCTN ISRCTN17805587
DOI https://doi.org/10.1186/ISRCTN17805587
EudraCT/CTIS number 2013-004055-20
Secondary identifying numbers 17391
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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-a-new-way-to-see-how-well-radium-223-is-working-reasure

Contact information

Ms Dalia Ismail
Scientific

The Institute for Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a patient information sheet
Scientific titleA phase II randomised trial of biomarkers to assess (dose) response in patients with metastatic castration resistant prostate cancer treated with radium-223
Study acronymREASURE
Study objectivesThe 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) studiedProstate cancer
InterventionPatients 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 typeOther
Primary outcome measureThe 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.
Secondary outcome measuresN/A
Overall study start date30/01/2015
Completion date01/12/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participantsPlanned Sample Size: 38; UK Sample Size: 38
Total final enrolment36
Key inclusion criteria1. 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 criteria1. 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 enrolment30/01/2015
Date of final enrolment30/06/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Institute for Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor information

Royal Marsden NHS Foundation Trust
Hospital/treatment centre

Fulham Road
London
SW3 6JJ
England
United Kingdom

Website http://www.royalmarsden.nhs.uk/pages/home.aspx
ROR logo "ROR" https://ror.org/0008wzh48
The Institute for Cancer Research
Research organisation

15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Funders

Funder type

Industry

Bayer Pharmaceuticals Plc (UK)

No information available

Results and Publications

Intention to publish date01/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planThe 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
HRA research summary 28/06/2023 No No
Results article Disease response in bone 03/10/2023 04/10/2023 Yes No

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.