The protocol was closed as a result of lack of any PSA response coupled with slow accrual. 1 patient progressed clinically ahead of any treatment method and was not incorporated while in the toxicity or efficacy analysis. 2 individuals who received study drug had been deemed ineligible as they did not meet entry PSA criteria of 3 consecutive rises in PSA but have been incorporated inside the toxicity evaluation. Kinase one describes the baseline demographic and clinical data with the 13 eligible patients. Median age was 65.five years, median baseline PSA at registration was eight.4 using a variety of two.2 to 77, Gleason sum was seven in 46.2% and 8?9 in a different 38.5%, and median Karnofsky functionality score was 90 . six sufferers had undergone prior radical prostatectomy and 5 had undergone definitive radiation therapy.
three individuals just about every had received salvage and adjuvant radiation therapy. Median time considering the fact that hormone initiation for that 13 eligible individuals was four.seven years . Median pretreatment PSA slope was one.1 ng/mL/month. Efficacy and Survival Individuals had been handled to get a median of 3 cycles with cilengitide. There were no PSA responses; 2 sufferers had skinase illness selleck chemical price Vatalanib at 12 weeks and eleven individuals had progressed by PSA criteria in the beginning assessment immediately after 3 cycles. Median ontreatment PSA slope was one.eight ng/mL/month . Time to PSA progression was 1.eight months . All individuals are off protocol therapy. By using a median followup of three.1 years , median overall survival has not been reached to the cohort; five of 13 evaluable patients have died. Remedy related toxicity Toxicity was evaluated by NCICTCAE criteria in all 15 handled patients like the two ineligible individuals.
Therapy was tolerated really properly without any grade 4 or larger adverse occasions reported , There were two grade 3 and 3 grade two adverse occasions . The patient who formulated osteonecrosis was not on bisphosphonates when he was diagnosed with avascular necrosis of the femoral head. There have been 22 grade Raltegravir 1 adverse occasions. Dose reduction to ?1 dose degree was desired in 1 patient . Correlative evaluation In patients examined at baseline for CTCs , only one had any CTCs reflecting the relative paucity of CTCs. For anyone with CTC information at progression , CTC enhanced from 0 to 1 , remained at 0 and decreased from 23 to 0 . In patients with baseline CEC data , median CEC number was 26 . eight patients had serial CEC counts. At progression , median CEC was 47 .
Minimal cell counts and RNA yield precluded correlative gene expression research. The trend of CECs on remedy is proven in inhibitor 3. The significance with the transient improve in CECs on treatment method is unclear.