Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Temsirolimus
- Conditions
- Prostate Cancer
- Sponsor
- Sandy Srinivas
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Reduction in Serum PSA
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).
Detailed Description
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need. New therapies that extend survival of patients beyond that provided by chemotherapy are needed. The mechanisms of tumor progression to castration-resistance are unclear, but preclinical studies suggest that functional loss of the tumor suppressor gene PTEN and subsequent up-regulation of Akt, which is upstream of mTOR, may be involved in prostate cancer progression and metastasis. Based on these observations, it is hypothesized that mTOR inhibitor temsirolimus may prolong hormone sensitivity and delay disease progression in castration-resistant prostate cancer patients before antiandrogen withdrawal. This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer.
Investigators
Sandy Srinivas
Assoc Prof-Med Ctr Line
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO)
Intervention: Temsirolimus
Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO)
Intervention: Casodex (bicalutamide)
Outcomes
Primary Outcomes
Reduction in Serum PSA
Time Frame: 12 weeks treatment, with primary outcome assessed at 16 weeks
Proportion of subjects with \> 50% drop in serum PSA as compared to baseline, assessed at 16 weeks