Trial Information
An Open Label Study of Exploratory Pharmacogenomics and Pharmacologic Effects of Neoadjuvant Oral Temsirolimus in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have a High Risk of Relapse
Inclusion Criteria
Inclusion criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a
minimum of 6 core biopsy samples.
- Subjects must be a candidate for radical prostatectomy
- No evidence of metastatic disease as determined by CT scans and bone scans
- More criteria apply
Exclusion Criteria:
- Subjects from whom sufficient diagnostic biopsy material is not available for full
characterization of the tumor
- Active Infection requiring antibiotic therapy, or serious intercurrent illness,
active bleeding, or ongoing urinary tract infection necessitating rapid or emergent
surgical resection
- Subjects who have had hormonal injection or implants which will last longer than 6
months
- More criteria apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
To determine the effects of oral temsirolimus on changes in phosphorylation state of proteins in the mTOR signaling pathway in tumor tissue and on phosphorylation state of mTOR pathway proteins and on global and targeted gene expression pattern PBMCs
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3066A1-132
NCT ID:
NCT00235794
Start Date:
January 2004
Completion Date:
September 2007
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|
Austin, Texas 78705 |