This phase I/IIa study is a multi-center, prospective, open-label study evaluating safety and
biological efficacy of up to six dose levels of Osteodex of patients with metastatic
castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing
three known substances; dextran, alendronate and guanidine.
The objective of the study is to define the maximum tolerable dose of Osteodex when given
every third week. The following objectives will also be evaluated: overall survival, PSA
response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and
assessment of pharmacokinetic parameters.