← 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 up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in tumor volume on pelvic MRI after neoadjuvant therapy

Number of patients with biochemical recurrence defined using the Prostate Cancer Clinical Trials Working Group 2 definition

Number of patients with pathological T0

+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

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

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

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,142 Total Patients Enrolled

14 Trials studying Prostate Cancer

1,044 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,577 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

Saum Ghodoussipour, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Frequently Asked Questions

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

What is the overall enrollment figure of this medical study?

"Affirmative, according to clinicaltrials.gov the trial was originally posted on June 20th 2017 and is currently recruiting 90 participants from a single site. The study's records were last edited November 16th 2022."

Answered by AI

Has the FDA sanctioned Radical Prostatectomy as a viable medical option?

"With Phase 2 trials providing evidence of safety, Radial Prostatectomy received a score of 2 on our team's risk assessment scale. However, no data exists to support its efficacy yet."

Answered by AI

Are recruitment efforts open for this examination?

"The clinical trial is still open to enrolment, as per the data posted on clinicaltrials.gov. This study was first published in June of 2017 and has since been updated November 16th 2022."

Answered by AI

Could you please elaborate on the other experiments that have been conducted related to Radical Prostatectomy?

"Currently, Radical Prostatectomy is the focus of 483 clinical studies, with 134 being in their third phase. The majority of these trials are based out of Duarte, California though there are 20271 sites running such investigations worldwide."

Answered by AI

What is the customary indication for Radical Prostatectomy?

"Radical Prostatectomy is typically used to treat scalp structure, though it has also been known to aid in the treatment of thyroiditis, ulcerative colitis and female infertility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

Saum Ghodoussipour 2017. "Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02949284.

All > Acth > Abiraterone Acetate