 4. Patients must have evidence of progression of disease based on any one of the following criteria: a PSA- progression is defined as 2 consecutive increments in PSA with an absolute change of at least 1ngmL over 4 weeks. b An increase by 25 of the product of bi-dimensional disease or 30 in maximum diameter or appearance of an unequivocally new lesion qualifies as progression. c Worsening symptoms clearly attributable to disease progression qualifies as progression e.g. worsening malignant bony pain. 