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Hormone Therapy
Darolutamide vs Enzalutamide for Prostate Cancer (ARACOG Trial)
Phase 2
Recruiting
Led By Monica Bertagnolli, MD
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL
Ability to swallow study tablets whole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks
Awards & highlights
ARACOG Trial Summary
This trial will compare cognitive outcomes of men with non-metastatic and metastatic castration-resistant prostate cancer treated with darolutamide or enzalutamide.
Who is the study for?
Men with advanced prostate cancer that's resistant to hormone therapy, either spread (metastatic) or not (non-metastatic). They must be able to swallow pills, have low testosterone from treatment, and be in fairly good health. Men who've had certain treatments like enzalutamide or darolutamide before, brain metastasis, seizures, dementia, or are at risk of falls can't join.Check my eligibility
What is being tested?
The study is testing the effects of two drugs on thinking skills in men with advanced prostate cancer. Half will take Darolutamide and half Enzalutamide along with standard hormone-blocking injections. Their cognitive functions will be measured using a special computerized test called CANTAB.See study design
What are the potential side effects?
Both Darolutamide and Enzalutamide can cause fatigue, high blood pressure, memory problems and confusion. There might also be risks like falls due to muscle weakness or dizziness. Each person may experience side effects differently.
ARACOG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is growing despite hormone therapy, with increasing PSA levels.
Select...
I can swallow pills without any issues.
Select...
My prostate cancer is confirmed and does not have neuroendocrine or small cell features.
Select...
My prostate cancer is either spreading (mCRPC) or not visible on scans (M0CRPC).
Select...
I can perform daily activities with little or no assistance.
Select...
My prostate cancer has spread or has not spread but is resistant to treatment.
ARACOG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 104 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Kringles
Secondary outcome measures
Change in lowest ranking domain
Crossover from enzalutamide to darolutamide and darolutamide to enzalutamide
Improve in cognitive function after crossover
+5 moreARACOG Trial Design
2Treatment groups
Active Control
Group I: Darolutamide (DARO)Active Control1 Intervention
Patients will take DARO at a dose of 600 mg (300 mg ×2 tablets) by mouth twice daily beginning on Day 1, of Week 1. Patients will take DARO throughout planned treatment period or withdrawal of consent or progression of disease requiring change in therapy.
Group II: Enzalutamide (ENZ)Active Control1 Intervention
Patients will take ENZ at a dose of 160 mg PO once daily (QD), beginning on Day 1, of Week 1. Patients will take ENZ throughout planned treatment period or withdrawal of consent or progression of disease requiring change in therapy.
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Who is running the clinical trial?
Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,900 Total Patients Enrolled
2 Trials studying Prostate Cancer
11,818 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,645 Total Patients Enrolled
38 Trials studying Prostate Cancer
25,787 Patients Enrolled for Prostate Cancer
Monica Bertagnolli, MDPrincipal InvestigatorAlliance Foundation Trials
11 Previous Clinical Trials
8,700 Total Patients Enrolled
1 Trials studying Prostate Cancer
504 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is growing despite hormone therapy, with increasing PSA levels.I will undergo radiation treatment for more than 21 days during the study.I can swallow pills without any issues.My prostate cancer is confirmed and does not have neuroendocrine or small cell features.I had chemotherapy for prostate cancer more than 6 months ago.I have previously used ENZ or DARO.My prostate cancer is either spreading (mCRPC) or not visible on scans (M0CRPC).I have a history of seizures or currently experience them.I can perform daily activities with little or no assistance.I am castrated with low testosterone levels and have been on continuous treatment if medically castrated.I have untreated or unstable brain metastasis.I have used experimental drugs targeting hormone activity before.I use opioids, but my dose is stable and doesn't affect my thinking.I have previously used apalutamide.My prostate cancer has spread or has not spread but is resistant to treatment.I am at risk of falling, as shown by taking more than 12 seconds on the TUG test.My cancer progressed while on abiraterone or I was on it for less than 12 weeks for advanced prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Darolutamide (DARO)
- Group 2: Enzalutamide (ENZ)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for enrolment in this clinical experiment?
"Affirmative, clinicaltrials.gov attests that this medical trial is actively seeking volunteers. It was initially advertised on August 17th 2021 and the latest revisions were made on April 19th 2022. A total of 132 participants will be recruited from 12 different sites for this research study."
Answered by AI
To what extent does DARO pose a risk to the health of participants?
"Our team at Power believes that Darolutamide (DARO) is moderately safe, and has thus been assigned a score of 2. This estimation stems from the fact that this drug is currently in Phase 2 clinical trials, meaning it has undergone some safety assessment but not yet proven efficacy."
Answered by AI
What is the upper limit for enrollment in this trial?
"To successfully carry out this trial, 132 qualified participants must be recruited. Bayer is the sponsor of this study and patients can enroll in Missouri Baptist Medical Center located in Saint Louis or University of California - San Francisco at Mount Zion based in San Francisco."
Answered by AI
What have been the outcomes of prior experiments featuring Darolutamide (DARO)?
"In 2005, the Rosemere Cancer Centre at Royal Preston Hospital pioneered studies on darolutamide (DARO). Since then, 97 trials have been concluded and 119 are active. Examples of these ongoing trial sites include Saint Louis in Missouri."
Answered by AI
How widely dispersed are the locations of this clinical experiment?
"12 different medical centres across the United States are participating in this trial. These locations include Saint Louis, San Francisco and Hooksett among other cities, so it is advised to choose the most proximal site for your convenience."
Answered by AI
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