NCT03827473

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Castration-Sensitive Prostate Carcinoma
• Metastatic Prostatic Adenocarcinoma
• Stage IV Prostate Cancer
• Stage IVA Prostate Cancer
• Stage IVB Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Given PO
DRUG	Antiandrogen Therapy	Given per standard of care
DRUG	Docetaxel	Given IV
DRUG	Prednisone	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-02-08
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2019-02-01
• Last updated: 2020-06-25
• Results posted: 2020-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study