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Antiandrogen

Enzalutamide for Prostate Cancer (DaroAcT Trial)

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12, 24, and 52 weeks for the randomization phase
Awards & highlights

DaroAcT Trial Summary

This trial is comparing the effects of two drugs, darolutamide and enzalutamide, on physical function in patients with castration-resistant prostate cancer.

Eligible Conditions
  • Prostate Cancer

DaroAcT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 week, 24 week and 52 week.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 week, 24 week and 52 week. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Worsening in TUG Time During the 24- Week Period.
Secondary outcome measures
Mean Change From Baseline in Accelerometer-assessed Proportion of Time Spent in Light to Vigorous Physical Activity Based on a Threshold of >100 Activity Counts Per Minute.
Mean Change From Baseline in Daily Physical Activity as Assessed by CPM, at 12 and 24 Weeks, and During the 24 Weeks and 52 Weeks From Baseline.
Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism
+16 more

Side effects data

From 2017 Phase 4 trial • 215 Patients • NCT02116582
34%
Fatigue
25%
Decreased appetite
18%
Asthenia
17%
Back pain
16%
Arthralgia
15%
Nausea
13%
Bone pain
13%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total

DaroAcT Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants treated with enzalutamideExperimental Treatment1 Intervention
Group II: Participants treated with darolutamideExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide (Nubeqa, BAY1841788)
2024
Completed Phase 3
~4180
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,747 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)
2019. "Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04157088.
~6 spots leftby Apr 2025
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