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Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

2014-08-27 03:17:44 | BioPortfolio

Summary

There is a clear need for novel effective agents in castration-resistant prostate cancer (CRPC), an entity previously referred to as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in this disease, none improve overall survival outside of chemotherapy. The mechanisms behind progression to castration-resistance are unclear, but preclinical studies suggest that 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, we hypothesize that inhibition of mTOR activity with an IV mTOR inhibitor, temsirolimus, may prolong hormone sensitivity and delay disease progression. We have received approval and drug support from the NCCN and Wyeth to study temsirolimus in castration-resistant prostate cancer before antiandrogen withdrawal in a phase II, single stage, non-randomized clinical trial. Forty patients who are currently on combined androgen blockade with bicalutamide, who have evidence of disease progression by PSA or bony metastasis will receive temsirolimus weekly for 13 weeks. Because evaluating new therapies in prostate cancer is uniquely challenging given its long natural history and relatively indolent nature, this study will employ an established surrogate endpoint for efficacy, prostate-specific antigen (PSA), which will permit preliminary evaluation of this combination in fewer patients and in less time than would otherwise be possible in this disease, and additionally evaluates secondary time-to-event outcomes. By co-targeting the androgen and PTEN/Akt/mTOR signaling pathways in castration-resistant prostate cancer, we see great potential to impact this pervasive disease.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostatic Neoplasms

Intervention

Temsirolimus

Location

Stanford University School of Medicine
Stanford
California
United States
94305

Status

Recruiting

Source

Stanford University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:44-0400

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Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Tumors or cancer of the PROSTATE.

A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

Tumors or cancer of the PROSTATE which can grow in the presence of low or residual amount of androgen hormones such as TESTOSTERONE.

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