Open-label Study of Androgen Receptor Inhibition With Darolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm

Study Identifier:
21516
CT.gov Identifier:
NCT05059236
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival.

To assess safety by gathering adverse event information throughout the duration of the study.

Patients in the active arm will be matched 1:1 to patients in the control arm using important baseline characteristics such as age, ECOG PS, extent of disease defined as low or high volume according to CHAARTED, and presence of bone and visceral metastases.

To assess whether the addition of darolutamide to ADT provides superior clinical efficacy in terms of progression-free survival (PFS) vs ADT alone in men diagnosed with mHSPC

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: Arm Intervention/treatment
    • Read More
  • Drug: Other: ADT
  • Drug: 2022 ASCO
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Histologically or cytologically confirmed adenocarcinoma of prostate. Participants may have begun androgen-deprivation therapy (up to 120 days prior to enrollment). Note: Relugolix is not permitted as ADT in this study.
    • Metastatic disease and will be stratified by presence of high volume or low volume disease.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
    • Adequate bone marrow, liver and renal function within 4 weeks of enrollment
    • At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment
    • Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met:
    • Therapy was discontinued >/= 12 months ago AND there was a clinical state without evidence of disease at least 12 months after completing adjuvant or neoadjuvant hormonal therapy, as defined by 1 of the following:
    • PSA < 0.1 ng/mL after prostatectomy plus hormonal therapy
    • PSA < 0.5 ng/mL and has not doubled above nadir after radiotherapy plus hormonal therapy
    • Therapy lasted no more than 24 months
    • Prior palliative radiotherapy allowed for participants, if commenced within 30 days before starting androgen deprivation.
    • Bicalutamide, nilutamide or flutamide are allowed as single-agent therapy
    Exclusion criteria
    • PSA met criteria for PSA progression
    • History of malignancy in the past 5 years, with the exception of basal cell and squamous cell carcinoma of the skin.
    • Had any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, hospitalization for any cardiac event, including conduction abnormalities
    • Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
    • Known brain/ leptomeningeal metastases
    • An active viral hepatitis (defined as Hepatitis B surface antigen [HBsAg] reactive or detectable [qualitative] HBV DNA defined as HCV Ribonucleic Acid [RNA] [qualitative] is detected), known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment
    • Uncontrolled hypertension as indicated by a resting systolic BP = 160 mmHg or diastolic BP = 100 mmHg despite medical management
    • A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
    • Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the participant and/or his compliance with study procedures or may interfere with the participant's participation in the study or evaluation of the study results.
    • Prior hormone therapy in the metastatic setting
    • Prior chemotherapy in the adjuvant or neoadjuvant setting
    • Concurrent use or previous exposure of 5-alpha reductase inhibitors (within 28 days before the start of darolutamide or 5 half-lives of the drug, whichever is longer)
    • Any Prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors, Cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigational CYP 17 as antineoplastic treatment for prostate cancer
    • Previous (within 28 days before the start of darolutamide or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
    • Contraindication to both CT and MRI contrast agent
    • Hypersensitivity to any of the study treatments, study treatment classes, or excipients in the formulation of the study treatments
    • Inability to swallow oral medications

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate