Condition category
Cancer
Date applied
21/01/2015
Date assigned
21/01/2015
Last edited
04/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Dalia Ismail

ORCID ID

Contact details

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

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 measures

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

14/05/2016

Reason abandoned

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

14/05/2016

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes