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Darolutamide + ADT for Prostate Cancer (ARANOTE Trial)
ARANOTE Trial Summary
This trial is testing whether adding the drug darolutamide to standard hormone therapy can help treat metastatic hormone sensitive prostate cancer.
ARANOTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARANOTE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 1209 Patients • NCT01715285ARANOTE Trial Design
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Who is running the clinical trial?
Media Library
- I have not had radiotherapy in the last 2 weeks.I am able to care for myself and perform daily activities.I cannot swallow pills.My bone marrow, liver, and kidneys are functioning well.I started hormone therapy for cancer not more than 12 weeks ago.I have not used specific hormone therapies, chemotherapy, or other treatments for prostate cancer recently.I haven't had a stroke, heart attack, severe heart issues, or heart surgery in the last 6 months.My blood pressure is high (over 160/100) despite taking medication.I haven't had any cancer except for certain skin, bladder cancers, or in situ cancers in remission in the last 5 years.My prostate cancer was confirmed by a lab test.My cancer has spread to other parts of my body.I have a GI condition or had surgery that may affect how I absorb medication.
- 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.
- Group 1: Darolutamide+ADT
- Group 2: Placebo+ADT
Frequently Asked Questions
What is the risk profile associated with Androgen deprivation therapy (ADT)?
"There is both anecdotal and scientific evidence in support of Androgen Deprivation Therapy (ADT), so it was given a safety rating of 3."
Are there any more places open for patients in this clinical trial?
"Yes. This trial, which was originally posted on February 23rd, 2021, is currently looking for participants, according to the information available on clinicaltrials.gov. The last update to the posting was on October 6th, 2022."
Have similar trials been conducted before?
"Androgen deprivation therapy (ADT) has been studied since 2016. The first clinical trial was sponsored by Orion Corporation and conducted that same year. After the initial Phase 3 study in 2016, Androgen deprivation therapy (ADT) was approved as a medication. As of now, there are 25 ongoing trials in 44 countries and 530 cities."
In how many different trial locations is this study being conducted today?
"There are 5 available sites for this trial in Granby, Burlington, and Montreal, as well as other 5 locations."
How many people are recruited to participate in this clinical trial?
"That is correct, the listing on clinicaltrials.gov indicates that this study is actively recruiting patients. This particular trial was first posted on February 23rd, 2021 and was last updated on October 6th, 2022. The research is hoping to enroll 665 patients from 5 different locations."
Does the literature on Androgen deprivation therapy (ADT) date back far?
"Currently, there are 25 active clinical trials studying Androgen deprivation therapy (ADT), with 9 of them in Phase 3. Although several of these trials are based in Toronto, Ontario, there are 1,385 total locations running trials for Androgen deprivation therapy (ADT) across the world."
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