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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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: temsirolimus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235794

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United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Layout table for additonal information Identifier: NCT00235794     History of Changes
Other Study ID Numbers: 3066A1-132
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents