Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

Prostate Adenocarcinoma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Stage IIB Prostate Cancer AJCC v8

• NCT number: NCT03412396
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 22, 2018
• Completion date: July 30, 2024