NCT03412396

Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of aggregate pathologic risk features that drive post-operative radiotherapy recommendations from 35% to 15%. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of 6 months (24 weeks) neoadjuvant apalutamide followed by radical prostatectomy for intermediate risk prostate cancer. II. To estimate the frequency of clinical complete responses and "near" complete responses (currently defined as \< 6 mm total tumor volume). III. To characterize the molecular features of the treated prostate cancers and link them to morphologic characterization. IV. To measure the 3-5 year biochemical recurrence rate of treated patients as a baseline to inform a larger phase III trial. OUTLINE: Patients receive apalutamide orally (PO) daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy. After completion of study treatment, patients are followed up at 12 months.

Conditions

• Prostate Adenocarcinoma
• Stage IIB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Apalutamide	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Radical Prostatectomy	Undergo radical prostatectomy

Timeline

• Start date: 2018-03-22
• Primary completion: 2024-10-03
• Completion: 2026-03-30
• First posted: 2018-01-26
• Last updated: 2026-03-19
• Results posted: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study