Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.