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
NCT ID: NCT02949284
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2017-06-20
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer
NCT03279250
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
NCT02903368
Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer
NCT02789878
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
NCT03412396
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy
NCT02849990
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To evaluate the effect of neoadjuvant androgen receptor antagonist ARN-509 (apalutamide) with or without abiraterone acetate, GnRH agonist, and prednisone on the feasibility of performing nerve-sparing radical prostatectomy (RP) in men with high-risk prostate cancer (PCa).
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive androgen receptor antagonist ARN-509 orally (PO) daily for 3 months. Patients then undergo radical prostatectomy.
ARM II: Patients receive GnRH agonist subcutaneously (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.
ARM III: Patients undergo radical prostatectomy.
After completion of study treatment, patients are followed up for 2 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (androgen receptor ARN-509, radical prostatectomy)
Patients receive androgen receptor antagonist ARN-509 PO daily for 3 months. Patients then undergo radical prostatectomy.
Androgen Receptor Antagonist ARN-509
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo radical prostatectomy
Arm II (ARN-509, abiraterone acetate, GnRH, prednisone, RP)
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.
Abiraterone Acetate
Given PO
Androgen Receptor Antagonist ARN-509
Given PO
Gonadotropin-releasing Hormone Analog
Given SC
Prednisone
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo radical prostatectomy
Arm III (radical prostatectomy)
Patients undergo radical prostatectomy.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo radical prostatectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abiraterone Acetate
Given PO
Androgen Receptor Antagonist ARN-509
Given PO
Gonadotropin-releasing Hormone Analog
Given SC
Prednisone
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo radical prostatectomy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with Eastern Cooperative Oncology Group performance scale (ECOG PS) 0 or 1
* Clinical stage T3 or less as demonstrated by abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) will be selected as the prostate is resectable
* Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
* Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
* Serum albumin \>= 3.0 g/dL
* Glomerular filtration rate (GFR) \>= 45 mL/min
* Serum potassium \>= 3.5 mmol/L
* Serum total bilirubin =\< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 × ULN, subject may be eligible)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 × ULN
* Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
* Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
Exclusion Criteria
* Patients with rectal or ureteral invasion will be considered to have unresectable disease
* History of any of the following:
* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial within 6 months prior to randomization
* Venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 6 months prior to randomization
* Clinically significant ventricular arrhythmias within 6 months prior to randomization
* Metastatic prostate cancer
* Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Saum Ghodoussipour
Professor of Surgery, RWJMS
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Saum Ghodoussipour, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale Cancer Center
New Haven, Connecticut, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-01496
Identifier Type: REGISTRY
Identifier Source: secondary_id
Pro20160000563
Identifier Type: -
Identifier Source: secondary_id
081603
Identifier Type: OTHER
Identifier Source: secondary_id
Pro20160000563
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.