CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 45 enrolled
Drug / intervention
Apalutamide +2 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/NCT03412396
NCT03412396Phase 2Active

A Single Arm Study of 6-Months Neoadjuvant Apalutamide Prior to Radical Prostatectomy in Intermediate Risk Patients to Reduce the Frequency of Pathologic Features That Drive Post-Operative Radiation Therapy

M.D. Anderson Cancer Center·interventional·Posted Jan 26, 2018·Updated Mar 19, 2026

In Brief

A Phase 2 clinical trial evaluating Apalutamide, Quality-of-Life Assessment, and 1 other intervention for Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8. Active but no longer recruiting, targeting 45 participants across 1 site.

Detailed Summary

This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2ActiveOverdue
201820192020202120222023202420252026
First PostedJan 26, 2018
Enrollment StartMar 22, 2018
Primary CompletionOct 3, 2024
Study CompletionMar 30, 2026
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 8.4 years ago

Interventions

Apalutamidedrug

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Radical Prostatectomyprocedure

Undergo radical prostatectomy