Status:
COMPLETED
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
Lead Sponsor:
University of Colorado, Denver
Conditions:
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Eligibility:
MALE
19+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other pl...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the incidence of metabolic syndrome within 12 months, as defined by the Adult Treatment Panel III, in patients treated with enzalutamide compared to standard andro...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven adenocarcinoma of the prostate; if pathology is unavailable, the principal investigator (PI) may also make a determination of prostate cancer based on unequivocal clinic data
- Patients with advanced prostate cancer suitable for systemic treatment defined as: having metastatic disease, a biochemical relapse after primary therapy, or patients in whom primary therapy is not appropriate or feasible; patients without metastatic disease will need evaluation for local therapy and deemed inappropriate or have refused this treatment option
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Age \> 18 years
- Must use a condom if having sex with a pregnant woman
- A male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
- Life expectancy estimated at \> 12 months
- Ability to understand and willingness to provide written informed consent document
Exclusion
- A history of androgen deprivation therapy; patients receiving hormonal therapy in the adjuvant and/or neoadjuvant setting must have discontinued therapy at least 6 months prior to day 1 of treatment AND have a serum testosterone level \>= 50 ng/dL AND cannot have received more than 18 months of previous ADT
- A history of orchiectomy
- Previous androgen blockade (e.g. antiandrogens) in the last 3 months
- Patients already meeting the criteria for metabolic syndrome as defined by the Adult Treatment Panel III Criteria which requires 3/5 parameters encompassing glucose control, blood pressure, lipids and waist circumference; patients with 2 of the parameters at baseline will be allowed enrollment provided that one of those risk factors is hypertension (\>= 130/\>= 85 mm Hg)
- Baseline hypogonadism as defined as a testosterone \< 50 ng/dL
- PSA \< 0.5 ng/dL
- Serum vitamin D 25, hydroxy (OH) \< 12 ng/mL
- Active hepatitis C virus
- Use of corticosteroids as defined by a daily dose of prednisone (or equivalent) of 5 mg or greater for more than 1 month continuously within 3 months of screening
- Corrected calcium \> 10.6 mg/dL
- Absolute neutrophil count \< 1500/uL
- Platelet count \< 100,000/uL
- Hemoglobin \< 9 g/dL
- Total bilirubin \>= 1.5 x upper limit of normal (ULN) (unless documented Gilbert's)
- Alanine aminotransferase or aspartate aminotransferase \>= 2.5 x ULN
- Creatinine \> 2 mg/dL
- Clinically significant cardiovascular disease as evidenced by: myocardial infarction within 6 months of screening; uncontrolled angina within 3 months of screening; New York Heart Association (NYHA) class 3 or 4 congestive heart failure; clinically significant ventricular arrhythmia; Mobitz II/2nd degree/or 3rd degree heart block without a pacemaker in place; uncontrolled hypertension (HTN) (systolic \> 180 mmHg or diastolic \> 105 mmHg at screening)
- Previous exposure to enzalutamide
- Use of an investigational therapeutic within 30 days
- History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agent
- Known or suspected brain metastasis or active leptomeningeal disease
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past; also, history of loss of consciousness or transient ischemic attack within 12 months of day 1 visit
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Key Trial Info
Start Date :
November 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02278185
Start Date
November 11 2015
End Date
July 18 2024
Last Update
May 11 2025
Active Locations (2)
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1
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
2
University of Colorado Health - Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524