Plain English Summary
Trial website
Additional identifiers
EudraCT number
2013-004055-20
ClinicalTrials.gov number
Protocol/serial number
17391
Study information
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
Acronym
REASURE
Study hypothesis
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
London Surrey Borders, 23/09/2014, ref: 14/LO/1385
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measure
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.
Secondary outcome measures
N/A
Overall trial start date
30/01/2015
Overall trial end date
01/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 38; UK Sample Size: 38
Participant 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
Recruitment start date
30/01/2015
Recruitment end date
30/06/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Institute for Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Sponsor information
Organisation
The Royal Marsden Foundation Trust
Sponsor details
Fulham Road
London
SW3 6JJ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Organisation
The Institute for Cancer Research
Sponsor details
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Bayer Pharmaceuticals Plc (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from reasure-icrctsu@icr.ac.uk
Intention to publish date
01/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list