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Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer — ACADEMIC  

Stage IV Prostate Cancer Clinical Trial

Official title:
ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer

Clinical Trial Summary

This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality of life between screening and month 12 of the study.

SECONDARY OBJECTIVES:

I. To assess prostate specific androgen (PSA) response rates across the entire population and compared between groups.

II. To assess impact of abiraterone and docetaxel on additional quality of life measurements and quality of life trends throughout the duration of the study.

III. To assess the potential clinical efficacy between treatment groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03827473
Study type Interventional
Source University of Utah
Contact
Status Terminated
Phase Phase 2
Start date February 8, 2019
Completion date July 31, 2019
View Details
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