Prostate Cancer Clinical Trial
Official title:
Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer
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).
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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