drugset / Trial / NCT00811031

Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)

NCT00811031 ↗

NaSingle-groupOpen-labelTreatment

Summary

Objectives: Primary: * To evaluate the association of the probability of increase in phosphorylation of platelet-derived growth factor receptor (PDGFR) of \> 0.5 in peripheral blood leucocytes following pre-operative docetaxel chemotherapy, with progression-free survival in localized castration-resistant prostate cancer (CRPC) Secondary: * To evaluate the association of the probability of increase in phosphorylated platelet-derived growth factor receptor (PDGFR) expression in peripheral blood leucocytes \> 0.5 with indices of tumor regression including PSA-decline by 50% and measures of objective regression of tumor by transrectal MRI following pre-operative docetaxel therapy. * Explore associations of probability of increase in phosphorylated PDGFR in peripheral blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal compartments in resected specimens. * Evaluate the association of probability of increase in phosphorylated PDGFR expression in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with overall survival outcomes. * Assess global quality of life measures at baseline and 6 and 12 months post-operatively. * Create a tissue archive comprising tumor and peripheral blood specimens as a suitable resource for future genomic and proteomic studies.

Timeline

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Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Background Prednisone Other / unclassified 5 mg Oral

Indications