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Darolutamide + ADT for Prostate Cancer
Study Summary
This trial is testing if adding darolutamide to ADT (a treatment to reduce testosterone levels) is more effective than ADT alone in treating high-risk prostate cancer.
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.Trial Design
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Who is running the clinical trial?
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- I can take care of myself and am up and about more than half of my waking hours.I have no signs of cancer spread in my body based on recent scans.I have a CAPRA-S score of 3 or higher and no lymph node involvement.My prostate cancer tissue from surgery is available for testing.I do not have any severe illnesses or conditions that are not under control.I had a surgery to remove my prostate and it's been 6 to 16 weeks since then.I am HIV positive, on treatment, and my viral load is undetectable.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have had cancer before, but it won't affect this trial's treatment.My Decipher score from the prostate surgery is 0.6 or higher.I have not received hormone therapy, chemotherapy, or any other systemic treatment for my prostate cancer.My hepatitis B virus load is undetectable with treatment.My cancer has not spread to the lymph nodes in my pelvis.My Decipher score is 0.6 or higher.
- Group 1: Arm B (ADT, darolutamide)
- Group 2: Arm A (ADT, placebo)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are some of the most common purposes for Darolutamide?
"Darolutamide can be used as an amino acid supplementation therapy, a skin irritation treatment, and an anger management therapy."
How many medical facilities are running this experiment?
"To date, this clinical trial has recruited patients from 100 different sites. While the specific locations of Danville, San Antonio and Des Moines are mentioned, there are 100 other sites where this trial is being conducted. If you are interested in participating, it might be best to choose a location close to you to reduce travel requirements."
Has Darolutamide been cleared by the FDA?
"Since this is a phase 3 trial, there is already some evidence of Darolutamide's efficacy and it has undergone multiple rounds of testing for safety, so we've given it a score of 3."
Are there any precedents for Darolutamide's use in medical treatment?
"The first clinical trials testing darolutamide were done in 2000 at Centre de Recherche Clinique du CHUS. So far, 1151 have completed. As of right now, there are 271 clinical trials underway, with a significant amount happening in Danville, Pennsylvania."
To the best of your knowledge, has anything like this been done before?
"There are 271 ongoing studies involving Darolutamide in 65 countries and 1820 cities. The first trial began in 2000 and, after reaching Phase 3, was approved. 1,151 total studies have been completed as of now."
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