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Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer

NCT04056754 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2019-08-14

No results posted yet for this study

Summary

Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole. Clinical studies have shown that abiraterone acetate can significantly reduce the level of prostate specific antigen (PSA) in PCa patients, and help to reduce tumors, extending the lifespan of patients with advanced PCa for several years, and the toxicity is acceptable.

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

Abiraterone Acetate

Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.

DRUG

Placebo

Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.

DRUG

Prednisone

Subjects administered 5mg prednisone twice daily in 28-day cycle.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2018-03-14
Completion
2019-07-16

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056754 on ClinicalTrials.gov