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A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

2017-08-13 15:49:43 | BioPortfolio

Summary

This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.

Description

This is a single center, single arm, phase II trial designed to evaluate the 12 month PSA complete response rate in patients with metastatic hormone sensitive prostate cancer treated with ADT, docetaxel and enzalutamide. The primary endpoint of this study will be 12-month PSA complete response rate, which will be assessed against a contemporary historical control rate for the combination of ADT and docetaxel alone in the metastatic hormone naÃ-ve setting. The study will be conducted at all participating sites across North and South Carolina within the Levine Cancer Institute network. Enrollment is anticipated to be completed within 24 months.

Study Design

Conditions

Prostate Cancer

Intervention

ADT+Docetaxel+Enzalutamide

Location

Carolinas Healthcare System
Charlotte
North Carolina
United States
28203

Status

Not yet recruiting

Source

Carolinas Healthcare System

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-08-13T15:49:43-0400

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PubMed Articles [16013 Associated PubMed Articles listed on BioPortfolio]

Targeting AXL overcomes resistance to docetaxel therapy in advanced prostate cancer.

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Multinucleated polyploidy drives resistance to Docetaxel chemotherapy in prostate cancer.

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Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

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).

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

Tumors or cancer of the PROSTATE.

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