Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

Phase 1

Terminated

• Conditions: Prostate Cancer; Metastatic Disease; Prostatic Neoplasms; Castrate-resistant Prostate Cancer (CRPC); Androgen-insensitive Prostate Cancer; Hormone-refractory Prostate Cancer
• Interventions: Drug: Temsirolimus; Drug: Casodex (bicalutamide)

• Registration Number: NCT01020305
• Lead Sponsor: Sandy Srinivas

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-25
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-10
• Results First Submitted: 2014-10-03
• Results First Submitted QC: 2014-10-03
• Last Update Submitted: 2014-10-03
• Results First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temsirolimus + Bicalutamide	Casodex (bicalutamide)	Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus + Bicalutamide	Temsirolimus	Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO)

Primary Outcome Measures

Name	Time	Method
Reduction in Serum PSA	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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States