Active — Not RecruitingPhase 2

A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

United States223 participantsStarted 2021-11-04

Plain-language summary

The purpose of the study is 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. The researchers want to learn how long it takes for the cancer to get worse (also known as "progression-free survival") by either increasing symptoms, new metastases, PSA rise or death. All participants will be on treatment and take darolutamide with ADT until their cancer spreads, they have a medical problem, or they leave the study. The results will then be compared with patients' results from another study who received ADT alone (CHAARTED). This study will also assess safety by gathering adverse event information throughout the duration of the study. An adverse event is any medical problem, related or not to study treatment that a participant has during a study. The study drug, darolutamide, is already available for doctors to prescribe to patients with prostate cancer that has not yet spread to other parts of the body. It works by blocking a protein called a receptor from attaching to a hormone called androgen that is found in men. This protein can also be found in prostate cancer cells. ADT is a treatment that doctors are currently able to prescribe to patients with mHSPC. ADT is used to lower the amount of the androgen hormone.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ≤ 28 days before medical castration to prevent flare. Exclusion Criteria: * PSA met criteria for PSA progression * History of malignancy in the past 5 years, with the e…

What they're measuring

Progression-free survival (PFS)

Timeframe: Approximately 12 months after end of enrollment

Trial details

NCT IDNCT05059236

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-30