A phase I/IIa study of safety and efficacy of Alpharadin® with docetaxel in patients with bone metastases from castration-resistant prostate cancer
To establish a recommended dose of Alpharadin to be used with docetaxel To investigate safety and explore efficacy of the recommended dose of Alpharadin used with the standard treatment regiment of decetaxel in patients with bone metastases from castration-resistant prostate cancer. Evaluate the feasibility of patient self-reporting of pain intensity and analgesic use via an interactive voice response system.
Histologically or cytologically confirmed adenocarcinoma of the prostate. Two or more bone metastases (hot spots on bone scan confirmed withing 12 weeks prior to study enrollment). Known castration-resistant disease. Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value within 6 months of first study regiment, each measurment atleast 1 week apart. Serum PSA equal or over 2ng/mL. Or documented bone metastases by the appearance of two or more new lesions on bone scintigraphy. Good performance status, and over the age 18. Life expectancy greater then 6 months. Adequate blood counts, renal function and liver function. The patient must be willing to comply with study visits and safety follow-up. The patient must be eligible for docetaxel.
The patient will receive the standard of care dosing of Docetaxel (75mg/m2) will be administered intravenously every 3 weeks with 5mg prednisone twice a day continuously orally. Docetaxel dosing will be preceded by pre-medication with dexamethasone. Alpharadin (radium-223) will be given intravenously. The dose (administered radioactivity) will be 25kBq/kg (body weight) or 50 kBq/kg (body weight) depending on when the patient enters the study. Multiple injections will be administered after Docetaxel at intervals of one time every 3 weeks or 6 weeks between each administration according to the dose escalation scheme. The number of injections will vary. Bone and Cat scan for restaging will be done after 12 weeks of treatment or sooner if clinically indicated by the physician. Subjects will be followed post study every 3 months for safety follow-up.
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