← Back to Search

Androgen Synthesis Inhibitor

ARN-509 +/− Abiraterone for Prostate Cancer

Phase 2

Recruiting

Led By Saum Ghodoussipour, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combo of drugs for high-risk prostate cancer patients undergoing surgery. The drugs lower androgen levels, which can cause prostate cancer growth. Prednisone may either kill the tumor cells or stop them from dividing.

Who is the study for?

Men with high-risk prostate cancer who are planning to undergo surgery can join. They must have a Gleason score >8 or PSA >20, be in good physical condition (ECOG PS 0 or 1), and have no metastatic cancer or severe heart conditions. Their blood counts and organ functions need to meet specific levels, they should not be on seizure threshold-lowering meds for at least 4 weeks before the trial, and agree to use effective contraception.

What is being tested?

The trial is testing if ARN-509 works better alone or with abiraterone acetate, GnRH agonist, and prednisone in treating prostate cancer before surgery. The goal is to see if these treatments can reduce the amount of androgen since it helps prostate cancer cells grow.

What are the potential side effects?

Possible side effects include fatigue, hot flashes, joint pain, nausea, decreased appetite, constipation or diarrhea. There may also be an increased risk of infections due to lowered immune system function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-surgical potency rate defined as proportion of patients with International Index of Erectile Function score >= 17

Secondary study objectives

Change in tumor volume on pelvic MRI after neoadjuvant therapy

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%

Dizziness

15%

Amylase increase

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Erectile dysfunction

Headache

Personality change

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anorexia

Atrial fibrillation

Anxiety

Bruising

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (androgen receptor ARN-509, radical prostatectomy)Experimental Treatment4 Interventions

Patients receive androgen receptor antagonist ARN-509 PO daily for 3 months. Patients then undergo radical prostatectomy.

Group II: Arm II (ARN-509, abiraterone acetate, GnRH, prednisone, RP)Active Control7 Interventions

Patients receive GnRH agonist SC on day 1, androgen receptor antagonist ARN-509 PO daily PO for 4 times, abiraterone acetate PO daily for 4 times, and prednisone PO daily for 3 months. Patients then undergo radical prostatectomy.

Group III: Arm III (radical prostatectomy)Active Control3 Interventions

Patients undergo radical prostatectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical Prostatectomy

2005

Completed Phase 2

~4550

Do I qualify?Apply below to find out