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Antiandrogen

Apalutamide for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Aragon Pharmaceuticals, Inc.
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 day-1, day 1 and day 15 (cycle 1); day 1 and day 15 (cycle 2) and day 1 (cycle 3).
Awards & highlights

Study Summary

This trial will study whether apalutamide affects heart function in men with CRPC.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day-1, day 1 and day 15 (cycle 1); day 1 and day 15 (cycle 2) and day 1 (cycle 3).
This trial's timeline: 3 weeks for screening, Varies for treatment, and day-1, day 1 and day 15 (cycle 1); day 1 and day 15 (cycle 2) and day 1 (cycle 3). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
QTc Fridericia (QTcF) parameter
Secondary outcome measures
Electrocardiographic parameters (HR, RR, PR, and QRS)
Electrocardiographic parameters (QT)
Electrocardiographic parameters T- and U-wave morphology
+6 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
74%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Amylase increase
15%
Dizziness
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Personality change
6%
Erectile dysfunction
6%
Headache
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anxiety
3%
Atrial fibrillation
3%
Bruising
3%
Anorexia
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ApalutamideExperimental Treatment1 Intervention
Prostate Cancer participants will receive the study drug on an outpatient basis except for Cycle 1 (Day 1 and Day 2) and Cycle 3 (Day 1), when intake must occur at study site under overnight fasted conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~3310

Find a Location

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
5,329 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,284 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,860 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 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
A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study
2015. "A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02578797.
~5 spots leftby Apr 2025
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