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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.
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.
Carolinas Healthcare System
Not yet recruiting
Carolinas Healthcare System
Published on BioPortfolio: 2017-08-13T15:49:43-0400
This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic...
This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in treating patients with prostate cancer that has spread to other places in the body (metastatic), ...
The purpose of the study is to understand if there is benefit in treatment with a medicine called enzalutamide in the re-treatment setting. Patients must have been previously treated with ...
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being ...
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Resistance to docetaxel is a major clinical problem in advanced prostate cancer. The overexpression of AXL receptor tyrosine kinase (AXL) has been correlated with chemotherapeutic drug resistance. How...
When advanced prostate cancer recurred during hormonal therapy and became the castration-resistant prostate cancer, "vintage hormonal therapy," such as antiandrogen alternating therapy or estrogen-rel...
Docetaxel is the first-line chemotherapy currently used to treat symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients. Although it provides survival benefits it is associated w...
Docetaxel is the only FDA-approved first-line treatment for castration-resistant prostate cancer (CRPC) patients. Docetaxel treatment inevitably leads to tumour recurrence after an initial therapeutic...
Abiraterone acetate (AA) and enzalutamide (ENZ) are oral therapies offering survival benefit to metastatic castration-resistant prostate cancer (mCRPC) patients. Despite the availability of multiple t...
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.