None listed
Conditions
Brief summary
Alsympca is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases. The aim of the study is to compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS). Patients will be randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consists of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient will be followed until 3 years after first study drug administration. Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals. All patients received BSoC (Best Standard of Care)
Interventions
Drug: Radium-223 dichloride 50 kBq/kg body weight (b.w.), 6 intravenous (IV) administrations separated by 4 weeks intervals
Sponsors
Algeta ASA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically or cytologically confirmed adenocarcinoma of the prostate - Known hormone refractory disease - Multiple skeletal metastases (greater than or equal to 2 hot spots) on bone scintigraphy - No intention to use cytotoxic chemotherapy within the next 6 months - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external beam radiation therapy (EBRT) for bone pain
Exclusion criteria
- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period - Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago - Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks - Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) - History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic computed tomography (CT) or chest x-ray within previous 8 weeks
Outcome results
None listed