Your session is about to expire
← Back to Search
Darolutamide + SBRT for Prostate Cancer
Study Summary
This trial is testing whether a new combination therapy of SBRT and Darolutamide can help improve progression-free survival in men with metastatic prostate cancer who have not yet received systemic therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My prostate cancer is confirmed and does not have certain aggressive features.I have 5 or fewer cancer spread sites, and none have been treated with radiation.I have more than 5 cancer spread sites or had radiation in the same area before.
- Group 1: Darolutamide (BAY1841788)+ SBRT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment open for this trial at present?
"Affirmative. According to the information held on clinicaltrials.gov, this medical trial is actively engaging patients in recruitment; it was initially posted on October 19th 2020 and most recently revised on September 20th 2021. Sixty-six individuals are needed for enrolment across 1 centre."
Are there any other experiments that have utilized stereotactic body radiotherapy (SBRT)?
"Currently, 24 investigations are running into the effectiveness of Stereotactic Body Radiation Therapy (SBRT). Of those studies 9 have progressed to Phase 3. Although Toronto is a major research hub for SBRT, there exists over 1400 active trial locations around the world."
What is the cap for participants in this experiment?
"Affirmative, according to the clinicaltrials.gov portal this medical trial commenced recruitment on October 19th 2020 and was last updated in September 2021; with 66 patients needed across 1 site."
Is this research protocol an innovative approach to treating the condition?
"Presently, 24 clinical trials for stereotactic body radiation therapy are live in 557 cities and 44 countries. The initial study began in 2016 through the sponsorship of Orion Corporation, involving 1,303 participants who reached Phase 3 drug approval stage before its completion. Since then, 30 additional experiments have been concluded."
Has the U.S. Food and Drug Administration authorized SBRT for medical use?
"The safety of SBRT was evaluated as a 2 based on the existing evidence in Phase 2 trials, which indicate some affirmation for its security but lack data to verify efficacy."
Share this study with friends
Copy Link
Messenger