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Steroid

ARN-509 + Abiraterone 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
Evidence of disease progression on ADT. Patients must have two serial rises in PSA from nadir, with at least 1 week between PSA measurements, with a minimum PSA of 2 ng/mL, OR patients must have radiographic evidence of progression. Nadir is defined as the lowest PSA value after beginning the most recent therapy for metastatic CRPC.
Castrate levels of testosterone (testosterone < 50 ng/dL) on androgen deprivation therapy (ADT). Patients who have not undergone orchiectomy will continue gonadotropin-releasing hormone (GnRH) agonist or antagonist therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new drug, ARN-509, to see if it is effective in treating prostate cancer when used in combination with other drugs.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have worsening cancer despite treatment, shown by rising PSA levels or new areas of cancer on scans. Major treatments like chemo should be at least a month ago, and they shouldn't be on certain drugs that affect the body's enzyme systems or have a history of seizures.Check my eligibility
What is being tested?
The trial is testing ARN-509 combined with abiraterone acetate and prednisone in men whose prostate cancer has spread and doesn't respond to hormone lowering therapy anymore. It's an early-phase study focusing on safety, how the body processes the drugs, and initial signs if it works against cancer.See study design
What are the potential side effects?
Possible side effects include issues from immune system reactions, changes in blood pressure or heart rhythm due to hormonal imbalances, liver function changes, fatigue, bone pain from disease sites, and potential interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has worsened despite hormone therapy, shown by rising PSA levels or scans.
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My testosterone levels are very low due to hormone therapy for cancer.
Select...
I can do most of my daily activities without help.
Select...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
My scans show cancer has spread, and a biopsy can be done.
Select...
I am older than 18 years.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) / Recommended Phase 2 dosage (RP2D)
Secondary outcome measures
Anti-tumor activity
PSA Response
Pharmacokinetics
+1 more

Side effects data

From 2019 Phase 2 trial • 90 Patients • NCT01790126
66%
Fatigue
41%
Gynaecomastia
41%
Nipple Pain
31%
Hot Flush
28%
Arthralgia
24%
Diarrhoea
21%
Dysgeusia
17%
Rash
17%
Abdominal Discomfort
14%
Flatulence
14%
Alopecia
14%
Hypercholesterolaemia
14%
Breast Tenderness
14%
Dizziness
14%
Nausea
10%
Dyspepsia
10%
Abdominal Pain
10%
Upper Respiratory Tract Infection
10%
Erectile Dysfunction
10%
Rash Maculo-Papular
10%
Tinnitus
10%
Depression
7%
Conjunctivitis
7%
Cough
7%
Constipation
7%
Weight Increased
7%
Muscular Weakness
7%
Dyspnoea
7%
Pruritus
7%
Heart Rate Irregular
7%
Eyelid Ptosis
7%
Musculoskeletal Pain
7%
Headache
7%
Memory Impairment
7%
Dysphonia
7%
Dyspnoea Exertional
7%
Rash Pruritic
7%
Anxiety
7%
Decreased Appetite
3%
Muscle Spasms
3%
Back Pain
3%
Pain in Extremity
3%
Libido Decreased
3%
Muscle Atrophy
3%
Weight Decreased
3%
Hypertriglyceridaemia
3%
Cognitive Disorder
3%
Haematuria
3%
Fall
3%
Rhinorrhoea
3%
Hypertension
3%
Insomnia
3%
Testicular Pain
3%
Gastrooesophageal Reflux Disease
3%
Vomiting
3%
Oedema Peripheral
3%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apalutamide
LHRHa + Apalutamide
Luteinizing Hormone Releasing Hormone Agonist (LHRHa)

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment3 Interventions
ARN-509 when combined with the approved dose of abiraterone acetate (1,000 mg daily) plus prednisone (5 mg daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARN-509
2013
Completed Phase 2
~110
Abiraterone acetate
2014
Completed Phase 3
~3440
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
5,368 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,278 Patients Enrolled for Prostate Cancer
Aragon Pharmaceuticals, Inc Clinical TrialStudy DirectorAragon Pharmaceuticals, Inc.
2 Previous Clinical Trials
217 Total Patients Enrolled
2 Trials studying Prostate Cancer
217 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (Steroid) Clinical Trial Eligibility Overview. Trial Name: NCT01792687 — Phase 1
Prostate Cancer Research Study Groups: Treatment
Prostate Cancer Clinical Trial 2023: Abiraterone acetate Highlights & Side Effects. Trial Name: NCT01792687 — Phase 1
Abiraterone acetate (Steroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01792687 — Phase 1

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
Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate
2013. "Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01792687.
~0 spots leftby May 2025
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