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AzTrials

Prostate CarcinomaPhase 3NCT04484818

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

A Phase 3 study testing Darolutamide, Goserelin Acetate and Leuprolide Acetate in people with Prostate Carcinoma, run by ECOG-ACRIN Cancer Research Group at 115 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Darolutamide, Goserelin Acetate and Leuprolide Acetate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
115 sitesUnited States
Study dates
1 Mar 2021to 31 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRE-REGISTRATION INCLUSION (STEP 0)
  • Patient must have undergone a radical prostatectomy (RP) and must be registered to step 0 of this study at least 6 weeks after but not more than 16 weeks after their radical prostatectomy
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2
  • Patient with a prior or concurrent malignancy within 5 years of registration, whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Show all 18Show fewer
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • For patients with no previous Decipher score: Tumor tissue specimen from prostatectomy must be available and ready to be shipped
  • For patients who have previously had Decipher score performed by Decipher Biosciences, they must have score of >= 0.6
  • For patients who did not have a Decipher score previously performed by Decipher Biosciences, they must have had a Decipher score of >= 0.6 assessed from the prostatectomy specimen submitted
  • For patients who did not have a Decipher score previously performed by Decipher Biosciences, patients must also have a CAPRA-S score >= 3. The CAPRA-S score is calculated by assigning points for PSA in ng/mL, surgical margin status, seminal vesicle invasion, and extra-capsular extension. Lymph node involvement will serve as an exclusion criteria and will not count towards CAPRA-S inclusion score. A CAPRA-S score is not required for patients who had a Decipher score previously performed by Decipher Biosciences
  • Patient must have an undetectable PSA (< 0.2ng/mL) obtained within 2 weeks prior to randomization
  • Leukocytes >= 3,000/mcL (obtained within 4 weeks prior to registration)
  • Absolute neutrophil count >= 1,000/mcL (obtained within 4 weeks prior to registration)
  • Platelets >= 75,000/mcL (obtained within 4 weeks prior to registration)
  • Total bilirubin =< institutional upper limit of normal (ULN) (obtained within 4 weeks prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 4 weeks prior to registration)
  • Glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 (obtained within 4 weeks prior to registration)

Who cannot join

  • PRE-REGISTRATION EXCLUSION (STEP 0)
  • Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer
  • Patient must not have pathologic evidence of pelvic lymph node involvement
  • Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient must not have pre or post-operative radiographic evidence of cancer recurrence or metastasis by abdominal and pelvic imaging (computed tomography [CT] abdomen/pelvis, whole body magnetic resonance imaging [MRI], MRI abdomen/pelvis, or equivalent, AND bone scan) which must be done before or after prostatectomy prior to randomization. If pre-operative risk does not indicate a need for bone scan, post-operative Decipher score of >= 0.6 indicates increased risk of metastatic disease and may be used to obtain CT abdomen/pelvis and bone scan prior to randomization

Trial locations and contacts

115 sites in 1 country.

115 sites in 1 country

United States115 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • GenesisCare USA - Clarkston

    Clarkston, Michigan, 48346

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • GenesisCare USA - Farmington Hills

    Farmington Hills, Michigan, 48334

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • GenesisCare USA - Lakewood Ranch

    Lakewood Rch, Florida, 34202

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • GenesisCare USA - Macomb

    Macomb, Michigan, 48044

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • GenesisCare USA - Madison Heights

    Madison Heights, Michigan, 48071

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Lahey Medical Center-Peabody

    Peabody, Massachusetts, 01960

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • GenesisCare USA - Plantation

    Plantation, Florida, 33324

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Audie L Murphy VA Hospital

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • University of Toledo

    Toledo, Ohio, 43614

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • GenesisCare USA - Troy

    Troy, Michigan, 48098

  • City of Hope Upland

    Upland, California, 91786

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Winchester Hospital

    Winchester, Massachusetts, 01890

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy With Androgen Deprivation Therapy With or Without Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from returning compared to ADT alone in patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether 12 months of androgen deprivation therapy (ADT) and darolutamide improves metastasis-free survival (MFS) compared to 12 months of ADT plus placebo in men with high risk prostate cancer (defined by Cancer of the Prostate Risk Assessment Post-surgical [CAPRA-S] score >= 3 and a high Decipher score (>= 0.6) [C3+D+]) who have undergone radical prostatectomy.

SECONDARY OBJECTIVES:

  1. To determine whether 12 months of ADT and darolutamide improves recurrence-free survival (RFS) compared to 12 months of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.

II. To determine whether 12 months of ADT and darolutamide improves event-free survival (EFS) compared to 12 months of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.

III. To determine whether 12 months of ADT and darolutamide improves overall survival (OS) compared to 12 months of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.

IV. To determine the rate of testosterone recovery and time to testosterone recovery in each treatment arm.

  1. To evaluate the safety and tolerability of ADT and darolutamide.

CORRELATIVE OBJECTIVES FOR EXPLORATORY BIOMARKERS:

  1. To discover a novel gene expression signature in the Decipher transcriptome platforms that is predictive of clinical outcome, as defined by the primary and secondary objectives of this study, in response to ADT by intensification with darolutamide versus ADT alone.

II. To assess the prevalence of subclasses of established transcriptome expression signatures and prospectively validate their predictive value for ADT response, these include: (i) androgen (AR) activity (ii) Basal-luminal subtyping based on modified PAM50, and (iii) ADT score.

III. To assess whether the spectrum of high Decipher scores (0.6-1.0), prostate-specific antigen (PSA) levels at presentation and post-radical prostatectomy (RP) and final pathology variables affect the response and outcome to ADT and darolutamide.

QUALITY OF LIFE (QOL) OBJECTIVES:

  1. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, at 18 months between the two arms. (Primary) II. To compare the change in overall quality of life, measured by FACT-P total score, from baseline to 18 months between the two arms. (Secondary) III. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 12 months between the two treatment arms. (Secondary) IV. To compare the change in subjective patient-reported cognitive function (FACT-Cognitive [Cog]) from baseline to 12 months between the treatment arms. (Exploratory) V. To compare subjective patient-reported cognitive function (FACT-Cog scores) at 12 months between the two treatment arms. (Exploratory)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive a placebo four times daily (QID) for 52 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive darolutamide QID for 52 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 36 months.

Being tested
Darolutamide, Goserelin Acetate, Leuprolide Acetate, Placebo Administration, Quality-of-Life Assessment
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarolutamideDrug

    Also called Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788

    Given PO

  • Goserelin AcetateDrug

    Also called ZDX, Zoladex

    Given via injection

  • Leuprolide AcetateDrug

    Also called A-43818, Abbott 43818, Abbott-43818, Carcinil

    Given IV

  • Placebo AdministrationDrug

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • TriptorelinDrug

    Also called 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532

    Given via injection

Study groups in NCT04484818
Study groupRoleWhat they receive
Arm A (ADT, placebo)Active comparatorPatients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive a placebo four times daily (QID) for 52 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Drug: Triptorelin
Arm B (ADT, darolutamide)ExperimentalPatients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive darolutamide QID for 52 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Darolutamide; Drug: Goserelin Acetate; Drug: Leuprolide Acetate; Other: Quality-of-Life Assessment; Drug: Triptorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metastasis-free survival (MFS)

    The primary comparison will be an intention-to-treat analysis of all randomized patients. The method of Kaplan and Meier will be used to characterize the time-to-event endpoints, and a logrank test will be used to compare these endpoints across treatments.

    Measured: From randomization to development of metastatic disease or death, whichever occurs first, assessed up to 36 months

Secondary outcomes (9)

  1. Recurrence-free survival (RFS)

    The method of Kaplan and Meier will be used to characterize the time-to-event endpoints, and a logrank test will be used to compare these endpoints across treatments.

    Measured: From randomization to any of the MFS events, pelvic lymph node recurrence or detectable prostate-specific antigen (PSA) (PSA >= 0.2 ng/mL, confirmed by a second PSA of the same level or higher), whichever occurs first, assessed up to 36 months

  2. Event-free survival

    The method of Kaplan and Meier will be used to characterize the time-to-event endpoints, and a logrank test will be used to compare these endpoints across treatments.

    Measured: From randomization to any of the RFS events, treatment with salvage radiation therapy with or without systemic therapy, or initiation of systemic therapy for presumed recurrence, whichever occurs first, assessed up to 36 months

  3. Overall survival

    The method of Kaplan and Meier will be used to characterize the time-to-event endpoints, and a logrank test will be used to compare these endpoints across treatments.

    Measured: From randomization to death by any cause or date last known alive, assessed up to 36 months

  4. Testosterone recovery rate

    Exact binomial confidence intervals will be used to describe the proportions of patients with testosterone recovery in each arm.

    Measured: At time of disease progression, assessed up to 36 months

  5. Time to testosterone recovery

    The method of Kaplan and Meier will be used to characterize the time-to-event endpoints, and a logrank test will be used to compare these endpoints across treatments.

    Measured: From randomization to a return of serum testosterone level to greater than or equal to lower limit of normal for the testosterone assay, assessed up to 36 months

  6. Incidence of adverse events

    Toxicity will be defined using the Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 78 weeks

  7. Change in quality of life: Functional Assessment of Cancer Therapy (FACT)

    Will be assessed by the Functional Assessment of Cancer Therapy (FACT) - Prostate, FACT - Cognitive, and Functional Assessment of Chronic Illness Therapy - Fatigue. Fatigue instruments at baseline, 6, 12 and 18 months, and descriptive statistics will be used to characterize quality of life over time in each arm. Each item is answered on a 5-point Likert-type scale, where a value of 0 indicates the statement is not applicable, and a value of 5 indicates the statement is applicable to the respondent. Subgroup analysis will be performed among patients who receive adjuvant radiation therapy and patients who do not receive adjuvant radiation therapy in each arm. Mixed effect models will be constructed as an exploratory analysis to estimate the time profile of quality of life assessments in the two arms and to evaluate treatment-by-time interactions.

    Measured: Baseline up to 18 months

  8. Overall quality of life: Functional Assessment of Cancer Therapy (FACT)

    Will be assessed by the Functional Assessment of Cancer Therapy (FACT) - Prostate total score. The total score can range from 0 to 156, where a higher value indicates a better quality of life. Mixed effect models will be constructed as an exploratory analysis to estimate the time profile of quality of life assessments in the two arms and to evaluate treatment-by-time interactions.

    Measured: At 18 months

  9. Change in Functional Assessment of Cancer Therapy (FACT) - Prostate score

    A paired t test will be used to compare Functional Assessment of Cancer Therapy (FACT) - Prostate scores at these two time points in each arm. The total score can range from 0 to 156, where a higher value indicates a better quality of life. A two-sample t test will be performed to compare the changes in FACT - Prostate scores from baseline to 18 months between the two arms. Mixed effect models will be constructed as an exploratory analysis to estimate the time profile of quality of life assessments in the two arms and to evaluate treatment-by-time interactions.

    Measured: Baseline up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start1 Mar 2021
  3. Primary completion9 Jun 2026
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484818
Sponsor's protocol ID
EA8183
Other IDs
NCI-2020-02383, EA8183, EA8183, U10CA180820
Status last verified
Jul 2026
First submitted
21 Jul 2020
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darolutamide, Goserelin Acetate and Leuprolide Acetate in people with Prostate Carcinoma, run by ECOG-ACRIN Cancer Research Group at 115 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metastasis-free survival (MFS) (time frame: From randomization to development of metastatic disease or death, whichever occurs first, assessed up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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