NCT02949284Active, not recruitingPhase 2
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
Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in treating patients with prostate cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 21 Oct 2016
- Start date
- 20 Jun 2017
- Primary completion date
- Sept 2026
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT02949284
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 20 Jun 2017 to the primary completion date, Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Clinical stage T4 (invasion into rectum or ureters) significantly increases the morbidity of the surgery
- Patients with rectal or ureteral invasion will be considered to have unresectable disease
- Metastatic prostate cancer
- Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)
Who the study is looking for
- Histologically proven adenocarcinoma of the prostate and: Gleason \> 8 OR prostatic specific antigen (PSA) \> 20 and more than 1 positive core
- 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
Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.