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

NCT00811031 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-07-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Taxotere

75 mg/m\^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.

DRUG

Prednisone

5 mg twice a day by mouth.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lance Pagliaro, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811031 on ClinicalTrials.gov