BAY88-8223, does response study in HRPC patients
The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
: - Histologically/cytologically confirmed adenocarcinoma of the prostate - Patient is hormone refractory with evidence of progressive disease: -- Patient must be maintained on androgen ablation therapy with LHRH agonist or have undergone orchiectomy -- Patient's testosterone level is required to be equal to or below 50 ng/dl -- Patients in which flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required -- Increase in PSA levels in two consecutive measurements with at least one week apart, demonstrating an increase over the reference (nadir) value, and with the final PSA >/= 5 ng/ml --- A reference PSA (nadir) value must be measured at least 4 weeks after the discontinuation of flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, and at least 6 weeks after discontinuation of bicalutamide --- If the third PSA value is lower than the second value, the patient could still be eligible, provided a fourth measurement obtained at least 1 week after the third PSA value, is grater than the second PSA value and >/= 5 ng/ml - Multifocal (>1) skeletal metastases confirmed by bone scintigraphy within 6 weeks - Bone pain with a score of at least 2 on BPI average pain, despite adequate use of analgesics, that correlates with areas of increased uptake (osteoblastic activity) on bone scintigraphy - Performance status: ECOG 0-2 or Karnofsky >/= 60% - Life expectancy: At least 3 months - Age more than 40 years - Laboratory requirements: -- Neutrophil count >/= 1,5 x 109/L -- Platelet count >/= 100 x109/L -- Hemoglobin > 95 g/L -- Bilirubin within normal institutional limits -- ASAT and ALAT <2,5 times upper limit of normal (ULN) - The patient is willing and able to comply with the protocol (including maintenance of patient diary, completion of pain assessment forms), and agrees to return to the hospital for follow-up visits and examinations - The patient has been fully informed about the study and has signed the informed consent form
- Has received an investigational drug within 4 weeks before the administration of radium-223, or is scheduled to receiving one during the study period - Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Has received prior hemibody external radiotherapy - Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium 188 for the treatment of bony metastases within the last year prior to inclusion - Has started treatment with bisphosphonates less than 3 months prior to administration of study drug - Patients experiencing hormone withdrawal syndrome, or are </= 4 weeks post withdrawal of antiandrogen therapy (6 weeks for bicalutamide) - Patients who have started steroids or changed to treatment with steroids within the last 4 weeks prior to administration of radium-223 - Has other clinically significant or symptomatic disease, which might interfere with the assessment of bone pain, e.g. spinal cord compression, compression or infiltration of a neural plexus, nerve root or peripheral nerves - Other currently active (relapse within the last 3 year) malignancy (except non-melanoma skin cancer), or known brain or visceral metastases dominating the clinical picture of the patient - Other serious illness or medical condition: -- any uncontrolled infection -- cardiac failure Classification III or IV (New York Heart Association) -- Crohn disease or Ulcerative colitis -- known bone fracture within 8 weeks
A double blind, dose response phase II, multicentre study of radium 223 (Alpharadin®) for the palliation of painful bone metastases in hormone refractory prostate cancer patients