An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235794
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : December 27, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

October 6, 2005
October 10, 2005
December 27, 2007
January 2004
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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
This is an exploratory biomarker study. Outcome is measured by effect of temsirolimus containing the neoadjuvant CCI-779 on phosphorylation of mTOR pathway proteins. This is measured by comparing pre-post treatment tissue and blood samples.
Complete list of historical versions of study NCT00235794 on Archive Site
  • Determine effects of oral temsirolimus on global and targeted gene expression; compare effects in the tumor and PBMCs; obtain preliminary information on potential antitumor effects; evaluate PK using whole blood and tumor tissue.
  • To evaluate the relationship between PTEN status and the pharmacodynamic/pharmacogenomic effects of temsirolimus and to determine the effects of temsirolimus on changes in protein expression patterns in the plasma
Effect of temsirolimus on gene expression will be measured by comparing pre-and post treatment blood and tissue samples
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An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
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
Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy
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Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Prostatic Neoplasms
Drug: temsirolimus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
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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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP