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

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