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A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT02677896•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

Detailed Description

Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over placebo when added to ADT as assessed by the primary endpoint of rPFS, subjects were eligible to transition to an open-label portion of the study.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Subject is considered an adult according to local regulation at the time of signing informed consent.
•Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
•Subject received randomized double-blind treatment in ARCHES
•Subject has not met any of the discontinuation criteria in the main ARCHES protocol
•Subject is willing to maintain ADT with LHRH agonist or antagonist or has had a bilateral orchiectomy.
•Subject is able to swallow enzalutamide capsules whole and to comply with study requirements throughout the study
•Subject and subject's female partner agree to follow contraception and sperm donation requirements in main protocol

Exclusion Criteria

•Once randomized at day 1, subject must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration).
•Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
•* Up to 3 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
•* Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1;
•* Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy;
•* Up to 6 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
•* Prior ADT given for \< 39 months in duration and \> 9 months before randomization as neoadjuvant/adjuvant therapy.
•Subject had a major surgery within 4 weeks prior to day 1.
•Subject received treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1.
+19 more criteria

Locations (203)

Site US10016

Homewood, Alabama, United States

Site US10007

Anchorage, Alaska, United States

Site US10008

Tucson, Arizona, United States

Site US10034

Fountain Valley, California, United States

Site US10056

La Jolla, California, United States

Site US10026

Santa Rosa, California, United States

Site US10035

Aurora, Colorado, United States

Site US10050

Denver, Colorado, United States

Site US10048

St. Petersburg, Florida, United States

Site US10054

Thomasville, Georgia, United States

Key Dates

Start Date

March 9, 2016

Primary Completion Date

October 14, 2018

Completion Date

July 31, 2024

Last Updated

October 24, 2025

Enrollment

1,150

ACTUAL participants

Conditions

Metastatic Hormone Sensitive Prostate Cancer

Interventions

Enzalutamide

DRUG

Placebo

DRUG

Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).

NCT05720130

Prostate CancerMetastatic Castration-resistant Prostate Cancer+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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