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NCT05059236 · ClinicalTrials.gov registry record · Phase 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.
A Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer, sponsored by Bayer.
- Active
- Registry status
- Phase 2
- Development phase
- 223
- Enrollment target
- 20
- Study locations
NCT05059236: Active Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer, sponsored by Bayer.
NCT05059236 is a Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer that is active but no longer recruiting, run by Bayer. The registered enrollment target is 223 participants, below the 659-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05059236, a Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 223 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Time interval from enrollment to PSA progression, clinical progression or death, whichever occurs first. PSA progression is defined as when the PSA demonstrates an increase that is more than 50% of nadir, taking as reference the lowest recorded PSA level since starting androgen deprivation therapy (ADT). Clinical progression is defined as increasing symptomatic bone metastases, radiographic progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v. 1.1) for soft tissue me
Conditions Studied
Interventions
- DRUG Darolutamide (BAY1841788, Nubeqa)
- OTHER ADT
Study Locations (20)
California
- Tower Urology - Los Angeles
- UCI Health Center for Urological Care - Orange
- UC San Diego Health - Moores Cancer Center - San Diego
- Providence Saint John's Cancer Institute - Santa Monica
Michigan
- Lieutenant Colonel Charles S. Kettles VA Medical Center - Oncology - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit Headquarters - Detroit
- Michigan Institute of Urology - Troy - Town Center Building - Troy
Georgia
- Brigham and Women's Hospital (BWH) - Surgery Urology - Atlanta
- Piedmont Cancer Institute - Atlanta - Atlanta
Illinois
- Northwestern Medicine - Urology - Chicago
- Northwestern University's Feinberg School of Medicine - Chicago
Nebraska
- GU Research Network, LLC - Oncology radiology - Omaha
- XCancer Omaha - Omaha
New Jersey
- New Jersey Urology - Clifton - Clifton
- New Jersey Urology - Voorhees - Voorhees Township
Alabama
- Urology Centers of Alabama, PC - Homewood - Homewood
Arizona
- Arizona Urology Specialists - Tucson - W Orange Grove - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2021-11-04 |
| Est. Completion | 2026-06-05 |
| Phase | Phase 2 |
What the registry record for NCT05059236 still lists
NCT05059236 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 659-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Metastatic Hormone-sensitive Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Darolutamide (BAY1841788, Nubeqa) is the first listed.
NCT05059236 names 20 study sites across 11 states, led by California, Michigan, Georgia.
Frequently Asked Questions
What is clinical trial NCT05059236 about?
NCT05059236 is a clinical study titled "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.". 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...
What is the current status of trial NCT05059236?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2021-11-04. Estimated completion is 2026-06-05.
What conditions does trial NCT05059236 study?
This clinical trial studies the following conditions: Metastatic Hormone-sensitive Prostate Cancer.
What interventions are being tested in trial NCT05059236?
The interventions under investigation include: Darolutamide (BAY1841788, Nubeqa) (DRUG), ADT (OTHER).
Who is sponsoring clinical trial NCT05059236?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05059236 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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