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The clinical trial identified as NCT02319837, known as EMBARK (Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer), is a Phase 3 study investigating a combination therapy for men whose prostate cancer is returning but has not yet spread to distant sites.

This trial is highly significant because it targets a critical window of intervention: the period of high-risk biochemical recurrence (BCR), where the Prostate-Specific Antigen (PSA) level is rising rapidly after initial curative treatment (like surgery or radiation), but imaging scans still show no metastasis.

📋 Trial Overview and Purpose

The primary goal of the EMBARK study was to determine if adding Enzalutamide to standard Leuprolide therapy (a form of Androgen Deprivation Therapy, or ADT) could delay the spread of cancer (metastasis) in men with high-risk nonmetastatic prostate cancer.

The study initially compared three treatment arms:

  1. Enzalutamide plus Leuprolide (Combination Therapy)
  2. Enzalutamide Monotherapy (Enzalutamide only)
  3. Leuprolide plus Placebo (Standard ADT)

The randomized, blinded portion of the study has concluded, and the trial is currently ACTIVE, NOT RECRUITING. It is continuing in an open-label format to gather long-term data.

🔬 Key Terminology

Term Explanation
Enzalutamide
A potent androgen receptor inhibitor (ARi) that blocks the effects of testosterone on prostate cancer cells.
Leuprolide
A Gonadotropin-Releasing Hormone (GnRH) agonist, which reduces the body's production of testosterone (chemical castration). This is a standard form of ADT.
Nonmetastatic
The cancer is confined to the prostate area or surrounding tissues; it has not spread to distant organs or bones.
Biochemical Recurrence (BCR)
A rise in PSA levels after primary treatment (surgery or radiation), indicating the cancer has returned, even if no tumors are visible on scans.
Metastasis-free Survival (MFS)
The primary endpoint, measuring the time from randomization until the patient develops detectable distant metastasis or dies from any cause.

✅ Eligibility and Participation Requirements

The study focused on men (minimum age 18) who had previously undergone radical prostatectomy or radiotherapy (or both) with curative intent.

Key inclusion criteria for this high-risk population included:

  • Confirmed prostate adenocarcinoma.
  • Rising PSA levels after primary treatment.
  • A rapid PSA doubling time (≤9\le 9 months), which is a strong indicator of aggressive disease.
  • Serum testosterone levels ≥150\ge 150 ng/dL.

Crucially, participants were excluded if they had any prior or present evidence of distant metastatic disease, ensuring the study focused specifically on preventing the disease from spreading.

📊 Measured Outcomes

The trial was designed to evaluate the effectiveness of the interventions primarily by measuring how long the treatments could prevent the cancer from spreading.

Primary Outcome

The main measure was Metastasis-free Survival (MFS). This endpoint assessed the difference in time until radiographic progression (cancer spread visible on scans) or death between the combination therapy group (Enzalutamide plus Leuprolide) and the standard ADT group (Leuprolide plus Placebo).

Key Secondary Outcomes

Secondary outcomes tracked the disease progression and overall health, including:

  • Overall Survival (OS): The time from randomization until death from any cause.
  • Time to PSA Progression: How long it took for the PSA levels to start rising again significantly.
  • Time to First Use of New Antineoplastic Therapy: How long participants could avoid needing additional cancer treatments.
  • Time to Distant Metastasis: Specifically tracking the time until the cancer spread to distant sites.

💡 Why Is This Study Important?

The EMBARK trial addresses a major clinical challenge: treating prostate cancer recurrence effectively before it becomes metastatic. Once prostate cancer spreads, it is generally considered incurable. By intervening aggressively with combination therapy (Enzalutamide and Leuprolide) during the high-risk nonmetastatic phase, researchers aimed to significantly extend the time patients live without metastasis, potentially improving long-term survival and quality of life.

The successful completion of the randomized portion and the ongoing open-label follow-up will provide critical data on the long-term safety and efficacy of these treatment strategies in preventing the progression of high-risk prostate cancer.

📢 Disclaimer: If you are considering participation in any clinical trial, or if you have questions about the results of this study, please consult with your healthcare provider. They can provide personalized medical advice based on your specific health history.

You can find comprehensive details about the study plan, eligibility, and outcomes in the Trial Radar Card View under the 'Study Plan' and 'Participation' tabs.

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Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Phase 3 1,068 Randomized Open-Label

Active, not recruiting
Clinical Trial NCT02319837 is designed to study Treatment for Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate. It is a Phase 3 interventional study that is active, not recruiting, having started on December 17, 2014, with plans to enroll 1,068 participants. Led by Pfizer, it is expected to complete by September 19, 2026. The latest data from ClinicalTrials.gov was last updated on July 8, 2025.
Brief Summary
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

Official Title

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

Conditions
Hormone Sensitive Prostate CancerProstate CancerCancer of the Prostate
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • MDV3100-13
  • C3431004 (Other Identifier) (Alias Study Number)
  • 2024-513521-23-00 (Registry Identifier) (CTIS (EU))
NCT ID Number
NCT02319837
Start Date (Actual)
2014-12-17
Last Update Posted
2025-07-08
Completion Date (Estimated)
2026-09-19
Enrollment (Estimated)
1,068
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEnzalutamide plus leuprolide
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks
Enzalutamide
Leuprolide Open Label
ExperimentalEnzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Enzalutamide
Active ComparatorLeuprolide plus placebo
Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm...Show More
Placebo (No longer applicable in Open Label study period)
Sugar pill to mimic enzalutamide
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide
MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.
From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide
MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by RECIST 1.1. Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, CT, or MRI) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.
From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression was defined as the time in months from randomization to the date of the first PSA value demonstrating progression, while participants were on study treatment, which was subsequently confirmed at least 3 weeks later. PSA progression date was defined as the date that a ≥25% increase and an absolute increase of ≥2 micrograms per liter (μg/L) (2 nanograms per milliliter \[ng/mL\]) above the nadir (or baseline for participants with no PSA decline by Week 25) that was confirmed by a second consecutive value at least 3 weeks later. For participants who had suspended treatment at Week 37 and later reinitiated treatment, baseline was reset as the last PSA assessment prior to or on the date of reinitiation of treatment.
From randomization until first PSA progression (up to Month 98)
Time to First Use of New Antineoplastic Therapy
Time to first use of new antineoplastic therapy was defined as the time in months from randomization to first use of new antineoplastic therapy for prostate cancer.
From randomization until first use of new antineoplastic therapy (up to Month 98)
Overall Survival (OS)
Overall survival was defined as the time in months between randomization and death due to any cause.
From randomization until death due to any cause (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Time to Distant Metastasis
The time to distant metastasis was defined as the time in months from randomization to the earliest objective evidence of distant soft tissue metastases or metastatic bone disease by blinded independent central review (BICR).
From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) at 36 Weeks on Study Drug
Undetectable PSA at 36 weeks was serum PSA levels \<0.2 ng/mL at Week 36. Percentage of participants with undetectable PSA at 36 weeks on study drug was calculated as the number of participants with undetectable PSA at Week 36 divided by the number of participants with PSA values at Week 36, and multiplied by 100.
At Week 36
Percentage of Participants Who Remained Treatment-free 2 Years After Suspension of Study Treatment at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)
Undetectable PSA at 36 weeks was serum PSA levels \<0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (\<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. Percentage of participants who remained treatment-free 2 years after suspension of study treatment at Week 37 was calculated as the number of participants who remained treatment-free 2 years after suspension of study treatment at Week 37 divided by the number of participants with treatment suspension and multiplied by 100.
From randomization until 2 years after Week 37 (up to Month 34)
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA
Undetectable PSA at 36 weeks was serum PSA levels \<0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (\<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. Percentage of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA was calculated as the number of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA divided by the number of participants with treatment suspension and multiplied by 100.
From randomization until 2 years after Week 37 (up to Month 34)
Time to Resumption of Any Hormonal Therapy Following Suspension at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)
Undetectable PSA at 36 weeks was serum PSA levels \<0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (\<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. The time to resumption of any hormonal therapy following suspension at Week 37 due to undetectable PSA was defined as the time in months between the date of treatment suspension at Week 37 due to undetectable PSA and the date that hormonal therapy was restarted.
From treatment suspension at Week 37 until resumption of any hormonal therapy (up to Month 98)
Time to Castration Resistance
Time to castration resistance applied only to participants receiving leuprolide treatment and was defined as the time in months from randomization to the first occurrence of radiographic disease progression by BICR, PSA progression or symptomatic skeletal event (SSE) whichever occurred first with castrate levels of testosterone (\<50 ng/dL).
From randomization to the first occurrence of radiographic disease progression, PSA progression or SSE, whichever occurred first with castrate levels of testosterone (up to Month 98)
Time to Symptomatic Progression
Time to symptomatic progression was defined as the time in months from randomization to development of a skeletal-related event, worsening of disease-related symptoms requiring initiation of a new antineoplastic therapy, or development of adverse events (AEs) and clinically significant signs and/or symptoms due to loco-regional tumor progression requiring opiate use, surgical intervention or radiation therapy, whichever occurred first.
From randomization until the first development of events defined as symptomatic progression (up to Month 98)
Time to First Symptomatic Skeletal Event (SSE)
Time to first symptomatic skeletal event was defined as the time in months from randomization to use of radiation therapy (external beam radiation therapy or radionuclides) or surgery to bone for prostate cancer, findings of clinically apparent pathologic bone fracture or of spinal cord compression, or new use of opiate and/or systemic antineoplastic therapy due to bone pain collected in the SSE case report form (CRF), whichever occurred first.
From randomization until the first development of events defined as SSE (up to Month 98)
Time From Randomization to Onset of Clinically Relevant Pain Progression, Defined as a 2-point or Greater Increase From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Question 3 Score
Time to clinically relevant pain progression was defined as the time from randomization to onset of pain progression, where clinically relevant pain progression was defined as a 2-point or greater increase from baseline in the BPI-SF question 3 score. BPI-SF is a self-administered questionnaire containing 9 main questions related to pain and analgesic medication use, where question 3 (paraphrased) is "On a scale of 0 \[no pain\] to 10 \[pain as bad as you can imagine\], please rate your pain at its worst in the last 24 hours" with higher score indicating worse pain.
From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score (up to Month 98)
Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score
Time to first deterioration of the FACT-P total score was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score. FACT-P total score is based on subscale scores of physical, social/family, emotional, and functional well-being, as well as 12 site-specific items to assess prostate-related symptoms, ranging 0-156, with higher score representing better quality of life.
From randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (All-causality) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023
An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day. Modified TEAEs (mTEAEs) were AEs that occurred during the modified treatment period (events occurring or worsening during the treatment suspension period after 30 days of last dose prior to treatment suspension were excluded). Reinitiated TEAEs (rTEAEs) were AEs that occurred with a start date during the dosing period after suspension and reinitiation of study treatment as defined by the reinitiation treatment period.
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) (All-causality) - at PCD Cut-off Date of 31 January 2023
An AE was any untoward medical occurrence (e.g., sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was defined as the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day. The severity of all TEAEs was evaluated by the investigator based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life-threatening) and grade 5 (death related to AE).
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Treatment-related) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023
An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from date of first dose of study treatment through at least 30 days after last dose of study treatment or start day of new antineoplastic drug therapy minus 1 day. Treatment-related TEAEs were TEAEs attributed to study drug (enzalutamide, placebo or leuprolide). mTEAEs were AEs that occurred during the modified treatment period (events occurring or worsening during the treatment suspension period after 30 days of last dose prior to treatment suspension were excluded). rTEAEs were AEs that occurred with a start date during the dosing period after suspension and reinitiation of study treatment (reinitiation treatment period).
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With SAEs (All-causality) During On-treatment Period, Modified Treatment Period and Treatment Reinitiation Period and SAEs (Treatment-related) During On-treatment period-at PCD Cut-off 31 Jan 2023
An AE was any untoward medical occurrence in a participant administered study drug/other protocol-imposed intervention regardless of attribution. SAEs were AEs resulting in any of the following outcomes/deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. On-treatment period was time from first dose date of study treatment through ≥30 days after last dose of study treatment or start day of new antineoplastic drug therapy -1 day. mSAEs were SAEs occurring during modified treatment period (events occurring/worsening during treatment suspension period after 30 days of last dose prior to treatment suspension were excluded). rSAEs were SAEs occurring with a start date during the dosing period after suspension and reinitiation of study treatment. Treatment-related SAEs were attributed to any study drug.
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Enzalutamide or Placebo Discontinuation - at PCD Cut-off Date of 31 January 2023
An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day.
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or Grade 4 Post-baseline in Hematology Laboratory Test Values - at PCD Cut-off Date of 31 January 2023
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Hematology laboratory abnormalities were graded according to CTCAE version 4.03 (Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death). This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from ≤Grade 2 at baseline to Grade 3 and Grade 4 post-baseline for the following parameters: hemoglobin, leukocytes, lymphocytes, neutrophils, platelets.
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or Grade 4 Post-baseline in Chemistry Laboratory Test Values - at PCD Cut-off Date of 31 January 2023
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Chemistry laboratory abnormalities were graded according to CTCAE version 4.03 (Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death). This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from ≤Grade 2 at baseline to Grade 3 and Grade 4 post-baseline for the following parameters: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, calcium, creatine kinase, glucose, magnesium, phosphate, potassium, sodium.
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Potentially Clinically Significant Vital Signs - at PCD Cut-off Date of 31 January 2023
Participants with potentially clinically significant abnormalities in vital signs were summarized for the following parameters: systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). Potentially clinically significant abnormalities were defined as (1) SBP (mmHg): \>180 and increase from baseline \>40; \<90 and decrease from baseline \>30; final visit or 2 consecutive visits change from baseline (CFB) ≥10, ≥15, ≥20; final visit or most extreme result ≥140, ≥180, ≥140 and ≥20 CFB, ≥180 and ≥20 CFB; (2) DBP (mmHg): \>105 and increase from baseline \>30; \<50 and decrease from baseline \>20; final visit or 2 consecutive visits CFB ≥5, ≥10, ≥15; final visit or most extreme result ≥90, ≥105, ≥90 and ≥15 CFB, ≥105 and ≥15 CFB; (3) HR (bpm): \>120 and increase from baseline \>30; \<50 and decrease from baseline \>20.
From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
  • Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
  • PSA doubling time ≤ 9 months;
  • Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
  • Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

  • Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
  • Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
  • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
  • Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
  • Major surgery within 4 weeks before randomization;
  • Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
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247 Study Locations in 17 Countries

Alabama

University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, IDS Pharmacy, Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham, Birmingham, Alabama, 35249, United States

Alaska

Alaska Urological Institute dba Alaska Clinical Research Center, Anchorage, Alaska, 99503, United States

Arizona

Urological Associates of Southern Arizona, PC, Tucson, Arizona, 85741, United States

California

Tower Hematology Oncology Medical Group, Beverly Hills, California, 90211, United States
Cedars-Senai OCC Pharmacy, Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, 90048, United States
University of California, Irvine Medical Center, Orange, California, 92868, United States
Sutter Medical Group, Vascular & Varicose Vein Center, Roseville, California, 95661, United States
Sutter Medical Group, Roseville, California, 95661, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States
University of California Davis Medical Center, Sacramento, California, 95817, United States
University of California, Davis, School of Medicine, Sacramento, California, 95817, United States

Colorado

The Urology Center of Colorado, Denver, Colorado, 80211, United States
Foothills Urology, P.C., Golden, Colorado, 80401, United States

Connecticut

Eastern Connecticut Hematology Oncology Associates, Norwich, Connecticut, 06360, United States

Florida

Lakeland Regional Health Hollis Cancer Center, Lakeland, Florida, 33805, United States

Georgia

Emory University Hospital, Atlanta, Georgia, 30322, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, 30322, United States

Illinois

Northwestern Medical Group, Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States

Indiana

First Urology, PSC, Jeffersonville, Indiana, 47130, United States

Kansas

The University of Kansas Hospital, Kansas City, Kansas, 66160, United States
Kansas City Urology Care, PA, Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, 66205, United States
GU Research Network/Wichita Urology Group, Wichita, Kansas, 67226, United States

Maryland

John Hopkins University Hospital, Baltimore, Maryland, 21287, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21287, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services, Baltimore, Maryland, 21287, United States
Chesapeake Urology Research Associates, Towson, Maryland, 21204, United States

Michigan

Comprehensive Urology - Macomb Office, Macomb, Michigan, 48044, United States
Comprehensive Urology - Royal Oak (Stephenson) office, Royal Oak, Michigan, 48067, United States

Nebraska

GU Research Network, LLC / Urology Cancer Center, Omaha, Nebraska, 68130, United States

Nevada

VA Lahontan Valley Outpatient Clinic, Fallon, Nevada, 89406, United States

New Jersey

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, 07920, United States

New York

Memorial Sloan Kettering Cancer Center Commack, Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center Westchester, Harrison, New York, 10604, United States
Memorial Hospital, New York, New York, 10065, United States
Sidney Kimmel Center for Prostate and Urologic Cancers, New York, New York, 10065, United States
Premier Medical Group of the Hudson Valley PC, Poughkeepsie, New York, 12603, United States
Memorial Sloan Kettering Cancer Center Rockville Centre, Rockville Centre, New York, 11570, United States
Associated Medical Professionals of New York, PLLC, Syracuse, New York, 13210, United States
Memorial Sloan Kettering Cancer Center Nassau, Uniondale, New York, 11553, United States

North Carolina

Duke Investigational Chemotherapy Services, Durham, North Carolina, 27710, United States
Duke Nuclear Medicine, Durham, North Carolina, 27710, United States
Duke University Medical Center, Durham, North Carolina, 27710, United States
Alliance Urology Specialists, PA, Greensboro, North Carolina, 27403, United States

Ohio

TriState Urologic Services PSC Inc., dba The Urology Group, Cincinnati, Ohio, 45212, United States
Mercy Health Jewish Hospital, Cincinnati, Ohio, 45236, United States
Clinical Research Solutions, Middleburg Heights, Ohio, 44130, United States
Southwest Urology, Middleburg Heights, Ohio, 44130, United States

Oklahoma

Stephenson Cancer Center, Oklahoma City, Oklahoma, 73104, United States

Oregon

Oregon Imaging Center, Eugene, Oregon, 97401, United States
Oregon Urology Institute, Springfield, Oregon, 97477, United States

Pennsylvania

Urologic Consultants of SE PA, Bala-Cynwyd, Pennsylvania, 19004, United States
Keystone Urology Specialists, Lancaster, Pennsylvania, 17604, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, 19083, United States
Honickman Centre, Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital, Bodine Buiding, Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University, Medical Oncology, Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, 19107, United States

South Carolina

Carolina Urologic Research Center, Myrtle Beach, South Carolina, 29572, United States

Tennessee

Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery, Nashville, Tennessee, 37232, United States
Vanderbilt Unversity Medical Center, The Urology Clinic, Nashville, Tennessee, 37232, United States

Texas

Urology Clinics of North Texas, PLLC, Dallas, Texas, 75231, United States
Houston Metro Urology, Houston, Texas, 77027, United States
Urology San Antonio Research, San Antonio, Texas, 78229, United States

Virginia

Henrico Doctor's Hospital, Henrico, Virginia, 23229, United States
Virginia Urology, Richmond, Virginia, 23235, United States
Urology of Virginia, PLLC., Virginia Beach, Virginia, 23462, United States

Alberta

Prostate Cancer Centre, Calgary, Alberta, T2V 1P9, Canada
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada

British Columbia

Vancouver Prostate Centre, Vancouver, British Columbia, V5Z 1M9, Canada

Manitoba

Manitoba Prostate Centre CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada

Nova Scotia

Nova Scotia Health Authority, Halifax, Nova Scotia, B3H 2Y9, Canada

Ontario

The Male/Female Health and Research Centre, Royal Court Medical Centre, Barrie, Ontario, L4M 7G1, Canada
Kingston General Hospital, Kingston, Ontario, K7L 2V7, Canada
Centre for Applied Urological Research, Kingston, Ontario, K7L 3J7, Canada
Hotel Dieu Hospital, Kingston, Ontario, K7L 5G2, Canada
Urology Associates/ Urologic Medical Research, Kitchener, Ontario, N2N 2B9, Canada
London Health Sciences Centre - Victoria Hospital, London, Ontario, N6A 5W9, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, M4N 3M5, Canada
University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada

Quebec

Urology South Shore Research, Greenfield Park, Quebec, J4V 2H3, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada
Ultra-Med Inc., Pointe-Claire, Quebec, H9R 4S3, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec, Québec, Quebec, G1R 2J6, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO, Québec, Quebec, G1R 3S1, Canada

New South Wales

Genesis Cancer Care NSW, Gateshead, New South Wales, 2290, Australia
Lismore Base hospital, Lismore, New South Wales, 2480, Australia
Liverpool Hospital, Liverpool, New South Wales, 2170, Australia
Macquarie University, North Ryde, New South Wales, 2109, Australia
Genesis Cancer Care, North Sydney, New South Wales, 2060, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, 2444, Australia
GenesisCare North Shore, St Leonards, New South Wales, 2065, Australia
The Tweed Hospital, Tweed Heads, New South Wales, 2485, Australia
Australian Clinical Trials Pty Ltd, Wahroonga, New South Wales, 2076, Australia
Sydney Adventist Hospital, Wahroonga, New South Wales, 2076, Australia
Calvary Mater Newcastle, Waratah, New South Wales, 2298, Australia
Westmead Hospital, Westmead, New South Wales, 2145, Australia
Illawarra Cancer Care Centre, Wollongong, New South Wales, 2500, Australia

NEW

Crown Princess Mary Cancer Centre, Westmead, NEW, 2145, Australia

Queensland

Icon Cancer Care Wesley, Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Chermside, Chermside, Queensland, 4032, Australia
Icon Cancer Care South Brisbane, South Brisbane, Queensland, 4101, Australia
Icon Cancer Foundation, South Brisbane, Queensland, 4101, Australia
Icon Cancer Centre Southport, Southport, Queensland, 4215, Australia

South Australia

Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia

Victoria

Box Hill Hospital, Box Hill, Victoria, 3128, Australia
Monash Medical Centre, Clayton, Victoria, 3168, Australia
Austin Health, Heidelberg, Victoria, 3084, Australia
Australian Urology Associates, Malvern, Victoria, 3144, Australia
Sunshine Hospital, St Albans, Victoria, 3021, Australia

Western Australia

Fiona Stanley Hospital, Murdoch, Western Australia, 6150, Australia

Upper Austria

Hospital Barmherzige Schwestern Linz, Linz, Upper Austria, 4010, Austria
Hospital Barmherzige Schwestern Linz, Department of Urology, Linz, 4010, Austria
Ordensklinikum Linz GmbH, Linz, 4020, Austria
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria, Salzburg, 5020, Austria
Department of Radiology, University Hospital Salzburg, Austria, Salzburg, 5020, Austria
Department of Urology,Paracelsus Medical University Salzburg, Salzburg, 5020, Austria
AKH - Medizinische Universität Wien, Vienna, 1090, Austria
Department of Internal Medicine I, Medical university Vienna, Vienna, 1090, Austria

Estado de Bahia

Hospital São Rafael S.A, Salvador, Estado de Bahia, 41253-190, Brazil

Paraná

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba, Paraná, 81520-060, Brazil

Rio Grande do Sul

CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo, Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda., Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, Rio Grande do Sul, 90610-0000, Brazil

São Paulo

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, São Paulo, 14784-400, Brazil
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP, Campinas, São Paulo, 13083-970, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo André, São Paulo, 09060-650, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda, Ijuí/RS, 98700-000, Brazil

Copenhagen N

Rigshospitalet - Copenhagen University Hospital, Copenhagen N, Copenhagen N, 2200, Denmark
Aarhus University Hospital, Arhus N, 8200, Denmark
Rigshospitalet - Copenhagen University Hospital, Copenhagen, 2100, Denmark
Rigshospitalet, Dept of Radiology, Copenhagen, 2100, Denmark
Odense University Hospital, Odense C, 5000, Denmark
Vejle Sygehus, Vejle, 7100, Denmark
Helsingin yliopistollinen keskussairaala, Helsinki, 00290, Finland
Oulun yliopistollinen sairaala, Oulu, 90220, Finland
Satakunnan Keskussairaala, Pori, 28500, Finland
Seinaejoen Keskussairaala, Seinäjoki, 60220, Finland
Tampereen yliopistollinen sairaala, Tampere, 33520, Finland
ICO- site Paul Papin, Angers, 49933, France
Clinique Pasteur - Lanroze Service Pharmacie, Brest, 29200, France
Clinique Pasteur - Lanroze, Brest, 29200, France
CHD Vendée, La Roche-sur-Yon, 85925, France
CHRU de Lille - Hopital Claude Huriez, Lille, 59037, France
ICM Val d'Aurelle, Montpellier, 34298, France
CHU de Nantes - Hotel Dieu, Nantes, 44000, France
Hopital Saint-Louis, Paris, 75475, France
Institut Mutualiste Montsouris, Paris, 75674, France
CHP Saint-Gregoire, Saint-Grégoire, 35760, France
ICO - site Rene Gauducheau, Saint-Herblain, 44805, France
Hia Begin, Saint-Mandé, 94160, France
Hopital Foch, Suresnes, 92151, France
Institut Gustave Roussy, Villejuif, 94800, France
Institut Gustave Roussy, Villejuif, 94805, France
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, 26100, Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, 26100, Italy
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, 26100, Italy
UO di Oncologia,Ospedale Civile degli Infermi, Faenza RA, 48018, Italy
UO di Radiologia, Ospedale Civile degli Infermi, Faenza RA, 48018, Italy
UO di Oncologia, Ospedale Civile Umberto I, Lugo RA, 48022, Italy
Uo di Radiologia, Ospedale Civile Umberto I, Lugo RA, 48022, Italy
Laboratorio Farmaci Antiblastici, IRCCS Istituto, Meldola (FC), 47014, Italy
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FC), 47014, Italy
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST), Meldola (FC), 47014, Italy
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A, Naples, 80131, Italy
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga, Orbassano (TO), 10043, Italy
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga, Orbassano (TO), 10043, Italy
Servizio di Farmacia, Ospedale Santa Maria delle Croci, Ravenna, 48121, Italy
Servizio di Radiologia, Ospedale Santa Maria Delle Croci, Ravenna, 48121, Italy
UO di Oncologia Medica, Ospedale Santa Maria delle Croci, Ravenna, 48121, Italy
Farmacia Interna, Ospedale degli Infermi, Rimini, 47923, Italy
UO Oncologia, Ospedale degli Infermi, Rimini, 47923, Italy
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani, Roma, 00152, Italy
U.O. di Oncologia Medica, Ospedale Santa Chiara, Trento, 38122, Italy
U.O. Medicina Nucleare, Ospedale Santa Chiara, Trento, 38122, Italy
U.O. Radiologia, Ospedale Santa Chiara, Trento, 38122, Italy
VU Medical Centrum, Department of Urology, Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum, Amsterdam, 1105AZ, Netherlands
Gelderse Vallei Ziekenhuis, Ede, 6710 HN, Netherlands
Catharina Ziekenhuis Eindhoven, Eindhoven, 5623 EJ, Netherlands
University Medical Centrum Groningen, Department Urologie, Groningen, 9713 GZ, Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, 8934 AD, Netherlands
Maastricht University Medical Center, Department of Urology, Maastricht, 6229 HX, Netherlands
Antonius Ziekenhuis, Sneek, 8601 ZK, Netherlands
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk, 80-952, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o., Słupsk, 76-200, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny, Słupsk, 76-200, Poland
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o, Torun, 87-100, Poland
Centrum Medyczne Melita Medical, Wroclaw, 50-449, Poland
EMC Instytut Medyczny Spolka Akcyjna, Wroclaw, 54-144, Poland
Fakultna nemocnica s poliklinikou F.D.Roosevelta, Banská Bystrica, 975 17, Slovakia
CUIMED, s.r.o., Urologicka ambulancia, Bratislava, 851 05, Slovakia
Vychodoslovensky onkologicky ustav, a.s., Košice, 041 91, Slovakia
Univerzitna nemocnica Martin, Martin, 036 59, Slovakia
UROEXAM, spol. s r.o., Nitra, 949 01, Slovakia
MILAB, Prešov, 080 81, Slovakia
Fakultna nemocnica s poliklinikou Zilina, Žilina, 012 07, Slovakia

Gyeonggi-do

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 13620, South Korea

Gyeongsangnam-do

Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, 50612, South Korea

Jeollanam-do

Chonnam National University Hwasun Hospital, Hwasun-gun, Jeollanam-do, 58128, South Korea
Gachon University Gil Medical Center, Incheon, 21565, South Korea
Severance Hospital. Yonsei University Health System, Seoul, 03722, South Korea
Asan Medical Center, Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System, Seoul, 06273, South Korea
Samsung Medical Center, Seoul, 06351, South Korea

Balearic Islands

Hospital Universitari Son Espases, Palma de Mallorca, Balearic Islands, 07010, Spain

Barcelona

Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, 08243, Spain

LA Coruna

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, LA Coruna, 15706, Spain
Hospital del Mar, Barcelona, 08003, Spain
Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio, Barcelona, 08036, Spain
Hospital Universitario Puerta del Mar, Cadiz, 11009, Spain
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia, Girona, 17007, Spain
Hospital Universitario de La Princesa, Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia., Madrid, 28007, Spain
Centro Oncologico MD Anderson International Espana, Madrid, 28033, Spain
Hospital Universitario Ramon Y Cajal, Madrid, 28034, Spain
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Complejo Hospitalario Universitario de Orense, Ourense, 32005, Spain
Corporacio Sanitaria Parc Tauli, Sabadell, 08208, Spain
Hospital Clinico Universitario de Salamanca, Salamanca, 37007, Spain
Instituto Valenciano de Oncologia IVO, Valencia, 46009, Spain
Sahlgrenska Universitetssjukhuset, Sahlgrenska, Gothenburg, 413 45, Sweden
Skanes Universitetssjukhus, Malmo, 205 02, Sweden
Universitetssjukhuset Orebro, Örebro, 70 185, Sweden
Sodersjukhuset AB, Stockholm, 118 83, Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, 17176, Sweden
Norrlands Universitetssjukhus, Umeå, 90 185, Sweden
Norrlands Universitetssjukhus, Umeå, 90185, Sweden
Akademiska Sjukhuset, Uppsala, 751 85, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, 807, Taiwan
China Medical University Hospital, Taichung, 40447, Taiwan
Taichung Veterans General Hospital, Taichung, 40705, Taiwan
National Taiwan University Hospital, Taipei, 10002, Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan District, 333, Taiwan

CITY of Glasgow

Ross Hall Hospital, Glasgow, CITY of Glasgow, G52 3NQ, United Kingdom

Devon

Royal Devon & Exeter Hospital, Wonford, Devon, EX2 5DW, United Kingdom

Greater London

Royal Free Hospital, London, Greater London, NW3 2QG, United Kingdom

Surrey

The Royal Marsden NHS Foundation Trust, Sutton, Surrey, SM2 5PT, United Kingdom

WEST Midlands

Cancer Centre, Queen Elizabeth Hospital, Birmingham, WEST Midlands, B15 2TH, United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol, BS2 8ED, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, G12 OYN, United Kingdom