ARCHES 9785-CL-0335

Study StatusEnrolling
Protocol9785-CL-0335
SponsorAstellas Pharma
Study Description

A Phase 3 Randomized, Double-blind, Placebo controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)   

Primary Endpoint

Evaluate the efficacy and safety of enzalutamide plus ADT versus placebo plus ADT in subjects with mHSPC

Inclusion Criteria

-Subject must be a man age ≥ 18 years of age
-Adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell or small-cell histology.
-Metastatic disease as documented by bone scan or metastatic lesions by CT or MRI. Subjects whose disease spread is limited to regional pelvic lymph nodes not eligible.
-Must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (medical or surgical castration)
-Patient life expectancy is ≥12 months .
-ECOG PS grade of 0 or 1
-Agrees to use a condom 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. Must also agree not to donate sperm during the study

Exclusion Criteria

-Prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer. Exceptions are:
-Major surgery within 4 weeks prior to enrollment
-Treatment with 5-a reductase inhibitors, estrogens, cyproterone within 4 weeks of enrollment
-Treatment with systemic glucocorticoids greater than the equivalent of 10mg per day of prednisone within 4 weeks of enrollment
-Treatment with Herbal medications that have known hormonal antiprostate cancer activity and or are known to decrease PSA levels within 4 weeks of enrollment.
-Prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for treatment of PCA or participation in clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g. TAK-70, ARN-509, ODM201)
-Known or suspected brain metastasis or active leptomeningeal disease
-History of invasive cancer within 3 years of screening except fully treated cancers with remote probability of recurrence.
-Lab values: AB Neutrophil count < 1500µl, platelet count <100000µl, HGB <10g/dl, TBili ≥1.5x upper limit of normal, ALT or AST ≥2.5x upper limit, Creat >2 mg/dl, Alb <3.0 g/dl
-History of seizure or condition which would predispose to seizure.
-History of loss of consciousness or TSA within 12 months of enrollment
-Clinically significant cardiovascular disease including: severe or unstable angina, MI, symptomatic CHF, ventricular arrhythmias, Mobitz II second-degree or third-degree w/o permanent pacemaker, Hypotension (SBP <86 ) at screening, Bradycardia (HR ≤45 bpm) on screening ECG, uncontrolled HTN (SBP ≥ 170 mmHG or DBP ≥ 105).
-GI disorder affecting absorption

Side Effects

Enzalutamide- Constipation, weight loss decreased appetite, diarrhea, falls, fatigue,  swelling of limbs, joint pain, muscle weakness, muscle and bone pain, back pain, headache, anxiety, trouble falling /staying asleep, hematuria, hot flashes, altered taste in mouth, mental impairment, broken bones, spinal cord compression, decreased WBC count, hallucination, dry skin, itching, restless leg syndrome, gynecomastia.

Interested in enrolling in this trial? Please call 717-431-2285.


< Back to Studies