A phase II randomised trial of biomarkers to assess (dose) response in patients with metastatic castration resistant prostate cancer treated with radium-223

Royal Marsden NHS Foundation Trust0 sites36 target enrollmentJanuary 21, 2015

Overview

2021 Results article in https://doi.org/10.1016/j.clgc.2021.03.020 Fracture risk (added 07/05/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37788117/ Disease response in bone (added 04/10/2023)

Registry

who.int

Start Date

January 21, 2015

End Date

December 1, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

•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\.

•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