Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)
|ClinicalTrials.gov Identifier: NCT00811031|
Recruitment Status : Withdrawn
First Posted : December 18, 2008
Last Update Posted : July 30, 2012
- 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)
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Taxotere Drug: Prednisone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer|
|Experimental: Taxotere + Prednisone||
75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
Other Name: docetaxelDrug: Prednisone
5 mg twice a day by mouth.
- Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR) [ Time Frame: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811031
|Principal Investigator:||Lance Pagliaro, MD||UT MD Anderson Cancer Center|