An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT04076059 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: 9785-CL-0336CTR20190132
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 28

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC). The study was conducted in two phases: Double-Blind treatment phase and open-label phase.

Conditions

Metastatic Hormone Sensitive Prostate Cancer

Keywords

Metastatic hormone sensitive prostate cancer; Androgen Deprivation Therapy (ADT); Xtandi; MDV3100; Enzalutamide

Outcome Measures

Primary Outcomes (1)

• Time to Prostrate Specific Antigen (PSA) Progression

  Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 microgram/liter (μg/L) (2 nanogram/milliliter \[ng/mL\]) above the nadir (i.e., lowest PSA value observed post baseline or at baseline), which was confirmed by a second consecutive value at least 3 weeks later. Time to event analysis was performed using Kaplan-Meier estimates.

  From the date of randomization to the first observation of PSA progression (up to 38 months)

Secondary Outcomes (8)

• Radiographic Progression-Free Survival (rPFS)

  up to 38 months

• Time to First Symptomatic Skeletal Event (SSE)

  Up to 38 months

• Time to Castration Resistance

  Up to 38 months

• Percentage of Participants With PSA Response (≥ 50%)

  Up to 38 months

• Percentage of Participants With PSA Response (≥ 90%)

  Up to 38 months

Study Arms (3)

Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)

EXPERIMENTAL

Participants received enzalutamide 160 mg capsules, orally once daily if tolerable, and continued ADT until radiographic disease progression was documented or until they started another investigational agent or new therapy for treatment of prostate cancer. Participants were to remain on study treatment until confirmed radiographic disease progression. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment.

Drug: Enzalutamide; Drug: Androgen deprivation therapy (ADT)

Placebo Plus ADT (Double Blind Phase)

PLACEBO COMPARATOR

Participants received enzalutamide-matching placebo capsules, orally once daily and continued ADT until radiographic disease progression was documented or until they started another investigational agent or new therapy for treatment of prostate cancer. Participants were to remain on study treatment until confirmed radiographic disease progression. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment."

Drug: Placebo; Drug: Androgen deprivation therapy (ADT)

Enzalutamide Plus ADT (Open-Label Phase)

EXPERIMENTAL

Participants who received placebo in double-blind phase and remaind on study treatment until confirmed radiographic disease progression received enzalutamide and continued ADT in open-label phase. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment.

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

Oral

Also known as: Xtandi, MDV3100

Enzalutamide Plus ADT (Open-Label Phase); Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)

Placebo DRUG

Oral

Placebo Plus ADT (Double Blind Phase)

Androgen deprivation therapy (ADT) DRUG

All participants were required to maintain ADT during study treatment, either using luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or having a history of bilateral orchiectomy.

Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase); Placebo Plus ADT (Double Blind Phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Double Blind treatment Phase:
• 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 measurable 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 androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (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 at screening.
• Subject has an estimated life expectancy of ≥ 12 months.
• Subject is able to swallow the study drug and comply with study requirements.
• A sexually active male subject with female partner(s) who is of childbearing potential is eligible if:
• Agrees to use a male condom starting at screening and continue throughout the study treatment and for at least 3 months after the last dose of study drug. If the male subject has not had a vasectomy or is not sterile at least 6 months prior to screening his female partner(s) is utilizing 1 form of highly effective birth control per locally accepted standards starting at screening and continue throughout study treatment and for at least 3 months after the male subject receives his last dose of study drug.
• Subject must agree to abstinence or use a condom throughout the study period and for at least 3 months after the last dose of study drug if engaging in sexual intercourse with a pregnant or breastfeeding partner(s).
• Subject must agree not to donate sperm from first dose of study drug through 3 months after the last dose of study drug.
• Subject agrees not to participate in another interventional study while on treatment.
• Open Label Phase:
• Before the sponsor's formal determination on study-wide unblinding, includes the subject who has evidence of radiographic progression as confirmed during the double-blind treatment (only apply to the subject in the placebo arm).
• Subject has not met any of the discontinuation criteria in the main protocol. Subject in the placebo arm who achieved confirmed radiographic progression in the double-blinded period is eligible.

You may not qualify if:

• Double-Blind Treatment Phase:
• 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 prostate-specific antigen (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 androgen receptor or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
• Subject received investigational agent within 4 weeks prior to day 1.
• Subject has known or suspected brain metastasis or active leptomeningeal disease.

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (28)

Site CN86022

Beijing, China

Location

Site CN86035

Beijing, China

Location

Site CN86024

Changchun, China

Location

Site CN86009

Changsha, China

Location

Site CN86016

Changsha, China

Location

Site CN86023

Changsha, China

Location

Site CN86025

Fuzhou, China

Location

Site CN86001

Guangzhou, China

Location

Site CN86028

Hangzhou, China

Location

Site CN86036

Hangzhou, China

Location

Site CN86004

Nanchang, China

Location

Site CN86002

Shanghai, China

Location

Site CN86003

Shanghai, China

Location

Site CN86010

Shanghai, China

Location

Site CN86013

Shanghai, China

Location

Site CN86014

Shanghai, China

Location

Site CN86027

Shanghai, China

Location

Site CN86020

Shenyang, China

Location

Site CN86011

Shenzhen, China

Location

Site CN86032

Suzhou, China

Location

Site CN86012

Tianjin, China

Location

Site CN86005

Ürümqi, China

Location

Site CN86019

Wuhan, China

Location

Site CN86026

Wuhan, China

Location

Site CN86021

Wuxi, China

Location

Site CN86038

Xi'an, China

Location

Site CN86017

Zhengzhou, China

Location

Site CN86029

Zhengzhou, China

Location

MeSH Terms

Interventions

enzalutamide; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Clinical Transparency
• Organization: Astellas Pharma China, Inc

astellas.resultsdisclosure@astellas.com

+86-(0)10-85216666

Study Officials

• Medical Science Manager

  Astellas Pharma China, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 3, 2019
• Study Start: September 11, 2019
• Primary Completion: November 18, 2022
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 17, 2026
• Results First Posted: November 18, 2023

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

CN (28)