Prostate cancer Cancer
Conditions
Interventions
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 aft
Sponsors
Royal Marsden NHS Foundation Trust
The Institute for Cancer Research
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Outcome results
None listed