An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Completed · Not applicable

Conditions studied: Prostatic Neoplasms

In brief

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

Key facts

Study ID

NCT00235794

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

50

Starts

2004-01-01

Expected to finish

2007-09-01

Last updated by the study team

2007-12-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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