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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


N/A
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

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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