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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Hormone Sensitive Prostate Cancer

In brief

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.

Key facts

Study ID: NCT02677896
Run by: Astellas Pharma Global Development, Inc.
People needed: 1150
Starts: 2016-03-09
Expected to finish: 2024-07-31
Last updated by the study team: 2025-10-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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 has metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan (for soft tissue). Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible.
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.
Inclusion Criteria for Open-Label Extension:
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

You may not qualify if…

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.
Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1.
Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1, intended for the treatment of prostate cancer.
Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Subject has absolute neutrophil count < 1500/μL, platelet count < 100000/μL or hemoglobin < 10 g/dL (6.2 mmol/L).
Subject has total bilirubin (TBL) ≥ 1.5 x the upper limit of normal (ULN) (except subjects with documented Gilbert's disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x the ULN .
Subject has creatinine > 2 mg/dL (177 μmol/L).
Subject has albumin < 3.0 g/dL (30 g/L).
Subject has a history of seizure or any condition that may predispose to seizure.
Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1.
Subject has clinically significant cardiovascular disease.
Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis
Exclusion Criteria for Open-Label Extension:
Subject has taken commercially available enzalutamide (Xtandi).
Subject's disease has progressed radiographically during the double-blind period of the study and treatment with study drug was stopped prior to study-wide unblinding. (Note: Subjects who progressed radiographically while in the double-blind portion of the study and continued treatment per protocol are allowed to participate in the open label extension.)
After study-wide unblinding, subject has started any new investigational agent or anti-neoplastic therapy intended to treat prostate cancer

Where it is running

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
Site US10015 — Chicago, Illinois, United States
Site US10043 — Springfield, Illinois, United States
Site US10045 — Jeffersonville, Indiana, United States
Site US10020 — West Des Moines, Iowa, United States
Site US10055 — Kansas City, Kansas, United States
Site US10017 — Towson, Maryland, United States
Site US10036 — Omaha, Nebraska, United States
Site US10018 — Lawrenceville, New Jersey, United States
Site US10025 — Newburgh, New York, United States
Site US10029 — Syracuse, New York, United States
Site US10068 — Charlotte, North Carolina, United States
Site US10009 — Concord, North Carolina, United States
Site US10014 — Durham, North Carolina, United States
Site US10060 — Greenville, North Carolina, United States
Site US10044 — Middleburg Heights, Ohio, United States
Site US10016 — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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