CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Abiraterone Acetate +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03279250
NCT03279250Phase 2Completed
CompareCT.gov

A Pre-Operative Study to Assess the Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence

M.D. Anderson Cancer Center·interventional·Posted Sep 12, 2017·Updated Aug 10, 2022

In Brief

A Phase 2 clinical trial evaluating Abiraterone Acetate, Apalutamide, and 3 other interventions for Prostate Adenocarcinoma and 4 related conditions. Completed, enrolled 86 participants across 1 site.

Detailed Summary

This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 12, 2017
Enrollment StartOct 13, 2017
Primary CompletionMay 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.8 years ago

Interventions

Abiraterone Acetatedrug

Given PO

Apalutamidedrug

Given PO

Gonadotropin-releasing Hormone Analogbiological

Given IM

Prednisonedrug

Given PO

Radical Prostatectomyprocedure

Undergo radical prostatectomy