Apalutamide with or without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients with High-Risk Prostate Cancer Undergoing Surgery
- 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 computed tomography (CT)/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
- 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
- History of any of the following: * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year 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)
- Patients on warfarin
I. To evaluate the effect of neoadjuvant 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 apalutamide orally (PO) daily for 3 months. Patients then undergo radical prostatectomy.
ARM II: Patients receive a GnRH agonist (leuprolide acetate intramuscularly [IM] or goserelin acetate subcutaneously [SC]) on day 1, apalutamide 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.
Trial Phase Phase II
Trial Type Treatment
Rutgers Cancer Institute of New Jersey
Isaac Yi Kim
- Primary ID 081603
- Secondary IDs NCI-2016-01496, Pro20160000563
- Clinicaltrials.gov ID NCT02949284