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About
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).
Full 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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA
Histologically-confirmed adenocarcinoma of the prostate, characterized as symptomatic castration-resistant prostate cancer (CRPC)
Serum PSA ≥ 2 ng/mL
Rising PSA on 3 consecutive occasions at least 1 week apart (not limited to the 30-day screening period)
Failure of bilateral orchiectomy and/or therapy with an LHRH agonist and bicalutamide
Castrate level of testosterone (< 50 ng/dL)
Currently being treated with bicalutamide
No prior antiandrogen therapy except bicalutamide
Age ≥ 18 years
Life expectancy > 6 months
Performance status
Ability to understand and the willingness to sign a written informed consent
EXCLUSION CRITERIA
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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