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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
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 • NCT0327925074%
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
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Erectile dysfunction
6%
Headache
6%
Personality change
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anorexia
3%
Atrial fibrillation
3%
Anxiety
3%
Bruising
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)
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
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,861 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,039 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,490 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Saum Ghodoussipour, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Isaac KimPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
216 Total Patients Enrolled