Spots Global Cancer Trial Database for Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

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Trial Identification

Brief Title: Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

Official Title: Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer

Study ID: NCT01020305

Conditions

Prostate Cancer

Prostatic Neoplasms

Castrate-resistant Prostate Cancer (CRPC)

Androgen-insensitive Prostate Cancer

Hormone-refractory Prostate Cancer

Metastatic Disease

Interventions

Temsirolimus

Casodex (bicalutamide)

Study Description

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.