Your session is about to expire
← Back to Search
Darolutamide + ADT for Metastatic Hormone-Sensitive Prostate Cancer (ARASEC Trial)
ARASEC Trial Summary
This trial will test if adding darolutamide to ADT will be more effective than ADT alone in men with hormone-sensitive prostate cancer that has spread to other parts of the body.
ARASEC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARASEC 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 2014 Phase 3 trial • 61 Patients • NCT02012218ARASEC Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have not had cancer in the last 5 years, except for skin cancer.My high blood pressure is not under control.I have taken medication to prevent flare before starting hormone therapy.I have cancer that has spread to my brain or its coverings.It's been over 4 weeks since my last major surgery and I've recovered from it.I've had hormone therapy before surgery or alongside other treatments, meeting all required conditions.My blood, liver, and kidney tests are normal.My prostate cancer is of a specific type: small cell or neuroendocrine.I have received hormone therapy for cancer that has spread.I had palliative radiotherapy less than 30 days before starting hormone therapy.I have not had a heart attack or other major heart issues in the last 6 months.I have an active viral infection or chronic liver disease needing treatment.I have been treated with specific prostate cancer medications before.I have a stomach or intestine problem that affects how I absorb medication.My prostate cancer is confirmed and I may have started hormone therapy but not with Relugolix.I cannot have contrast agents used in CT or MRI scans.I cannot swallow pills.I have used or am using medication that affects hormone levels.I have had chemotherapy before surgery or as an additional treatment.I am able to care for myself and perform daily activities.My cancer has spread, and it's classified as either high or low volume.
- Group 1: Darolutamide+ADT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Have there been any other research endeavors exploring the potential implications of ADT?
"Research into ADT began in 2016 when the trial NCT02799602 was initiated. 22 studies have since been concluded, with an additional 24 undergoing enrollment at present time--many of these located around Bala-Cynwyd, Pennsylvania."
What is the upper limit of participants involved in this experiment?
"Affirmative. The clinicaltrial.gov website contains information showing that this trial is currently open to the public, and was first published on November 29th 2021. An update was made on November 14th 2022 with a goal of recruiting 200 patients from 10 centers."
Is the intake period for this clinical trial still ongoing?
"According to the data hosted on clinicaltrials.gov, this is an ongoing medical trial that was first introduced 29th November 2021 and recently updated 14th November 2022."
How many healthcare centers are currently administering this experiment?
"At present, 10 medical centres are enrolling patients in this study. These sites stretch from Bala-Cynwyd to New york City and Los Angeles amongst other metropolitan areas. Therefore it is advisable for participants to select the closest facility that can accommodate them to limit travel demands if they decide to join the trial."
What potential risks are associated with androgen deprivation therapy?
"As a Phase 2 trial, ADT's safety has been partially tested and was appraised with a score of 2 on the scale. No data exists to support it effectiveness at this time."
Is this investigation unprecedented in its scope?
"At the present moment, 24 separate clinical trials for ADT are taking place in 557 cities and 44 nations. The groundwork of this research was laid by Orion Corporation's Phase 3 study which commenced in 2016 with 1303 patients; since then, 22 further investigations have been conducted."
Share this study with friends
Copy Link
Messenger