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Androgen Synthesis Inhibitor

Apalutamide + Abiraterone Acetate + Prednisone for Prostate Cancer

Phase 3

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

Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2

Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years and 10 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of two treatments for metastatic castration-resistant prostate cancer: apalutamide with abiraterone acetate and prednisone, versus abiraterone acetate and prednisone alone.

Who is the study for?

Men with advanced prostate cancer that hasn't spread to the brain and haven't had chemotherapy. They must have a specific type of tumor (adenocarcinoma), evidence of metastasis, and show cancer progression despite hormone therapy. Prior use of certain anti-androgens is allowed if followed by disease progression.Check my eligibility

What is being tested?

The trial tests if adding Apalutamide to standard treatment with Abiraterone Acetate and Prednisone improves outcomes in men with metastatic castration-resistant prostate cancer who haven’t received chemotherapy compared to the standard treatment alone.See study design

What are the potential side effects?

Possible side effects include fatigue, digestive issues, skin rash, weight loss, joint pain, high blood pressure, and potentially increased risk for falls or fractures due to bone weakening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has worsened, shown by rising PSA levels or changes in scans.

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I stopped taking my first-generation anti-androgen medication over 6 weeks ago and my prostate cancer is still getting worse.

Select...

I have been diagnosed with prostate adenocarcinoma.

Select...

My cancer has spread, confirmed by scans, with any lymph node spread larger than 2cm.

Select...

My prostate cancer is growing despite hormone therapy, with rising PSA levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years and 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years and 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years and 10 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

Radiographic Progression-free Survival (rPFS)

Secondary outcome measures

Overall Survival (OS)

Time to Chronic Opioid Use

Time to Initiation of Cytotoxic Chemotherapy

+1 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

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Personality change

Erectile dysfunction

Headache

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anxiety

Atrial fibrillation

Bruising

Anorexia

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: AAP and apalutamideExperimental Treatment3 Interventions

Participants will receive apalutamide 240 milligram (mg) (4*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).

Group II: Group 2: AAP and PlaceboPlacebo Group3 Interventions

Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Apalutamide

2015

Completed Phase 2

~3310

Abiraterone acetate

2014

Completed Phase 3

~3440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor

16 Previous Clinical Trials

4,392 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

3,958,923 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (Androgen Synthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02257736 — Phase 3

Prostate Cancer Research Study Groups: Group 1: AAP and apalutamide, Group 2: AAP and Placebo

Prostate Cancer Clinical Trial 2023: Abiraterone acetate Highlights & Side Effects. Trial Name: NCT02257736 — Phase 3

Abiraterone acetate (Androgen Synthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02257736 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Apalutamide taken by patients?

"Apalutamide has been proven to be an effective treatment for thyroiditis, non-metastatic prostate cancer, and ulcerative colitis."

Answered by AI

How many different research facilities are coordinating this study?

"There are 59 different locations where this trial is being conducted, with sites in London, Richmond, Kelowna, and other cities. If you are selected to participate in the trial, you will be assigned to a site close to you in order to minimize travel."

Answered by AI

Are there precedent studies which have used Apalutamide?

"At the moment, there are 397 Apalutamide clinical trials underway. Of these, 110 are in the third and final stage. Most of these studies are located in Duarte, California, but there are a total of 18915 locations running trials for this treatment."

Answered by AI

Has Apalutamide met the Food and Drug Administration's standards for safety and efficacy?

"Apalutamide has been evaluated in Phase 3 trials, which assesses both efficacy and safety. There is a significant amount of data to support Apalutamide's safety, so it received a score of 3."

Answered by AI

Are there any vacancies for participants in this trial?

"Right now, this study isn't looking for any more patients. It was originally posted on November 26th, 2014 and was updated on October 25th, 2022. If you're looking for other studies, there are 1274 trials for prostate cancer and 397 for Apalutamide admitting patients."

Answered by AI