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 places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02278185.
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 androgen deprivation therapy.
SECONDARY OBJECTIVES:
I. To determine the incidence of metabolic syndrome within 6 months, as defined by the Adult Treatment Panel III, in patients treated with enzalutamide compared to standard androgen deprivation therapy.
II. To assess bone health, as measured by a dual-energy x-ray absorptiometry (DXA) scanner.
III. To assess body composition (sarcopenic obesity), as measured by measurements of fat on computed tomography (CT).
IV. To assess quality of life (QOL), as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Sexual Health Inventory in Men (SHIM).
V. To assess time to prostate-specific antigen (PSA) progression and time to radiographic progression.
VI. To assess the incidence of developing individual risk factors, or components, which comprise metabolic syndrome.
VII. To assess the change in high-sensitivity (hs)-C-reactive protein (CRP) as a marker of inflammation.
VIII. To assess the safety and tolerance of enzalutamide or androgen deprivation therapy (ADT).
IX. To assess the change in physical function as measured by the Short Physical Performance Battery (SPPB).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive enzalutamide orally (PO) once daily (QD) for 12 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.
After completion of study treatment, patients are followed up at 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorElizabeth Riley Kessler
