An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Wyeth

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Drug: temsirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00235794

3066A1-132

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)