Skip to main content

Genistein in Preventing Cardiometabolic Dysfunction in Patients with Prostate Cancer Undergoing Androgen Deprivation Therapy

Trial Status: Active

This pilot phase II randomized trial studies genistein in preventing or reducing diabetes (blood sugar), heart, or blood vessels disease (cardiometabolic dysfunction) in patients with prostate cancer undergoing androgen deprivation therapy. Androgen is a male hormone that binds to androgen receptors inside the cancer cells, which causes the cancer cells to grow. Antiandrogen therapy or androgen deprivation therapy prevents this from happening. Despite the benefits of antiandrogen therapy, it is associated with an increased risk of cardiovascular dysfunction, such as high blood sugar and / or high cholesterol. Genistein is a natural supplement that comes from soy that in studies has been shown to decrease blood glucose and cholesterol, and it may prevent or reduce cardiometabolic dysfunction in patients receiving androgen deprivation therapy.

Inclusion Criteria

  • Medical indication for androgen deprivation therapy (ADT) via luteinizing hormone-releasing hormone (LHRH) analog +/- oral anti-androgen
  • Diagnosis of prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Life expectancy > 6 months
  • Ability to provide informed consent

Exclusion Criteria

  • Transmural myocardial infarction, unstable angina, or congestive heart failure requiring hospitalization within the last 6 months
  • Acute coronary event within the past month
  • Chronic liver disease
  • Current use of cytotoxic or immunosuppressive drugs
  • Chronic glucocorticoid or acute glucocorticoid or other synthetic steroid intake within the last month
  • Chronic diarrhea or malabsorptive diseases (e.g., Crohn’s disease)
  • Stage 5 chronic kidney disease or need for hemodialysis
  • Supplemental oxygen dependency
  • Brain metastasis
  • Severe cognitive dysfunction impairing ability to provide informed consent or consume study drug
  • Dysphagia or requirement for artificial feeding
  • Surgery or hospitalization within the last month
  • Chemotherapy or radiation therapy within the last 60 days
  • Type 1 or type 2 diabetes
  • Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
  • History (hx) of organ transplant
  • ECOG performance status > 2

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Jessica Alvarez
Phone: 404-727-1390

PRIMARY OBJECTIVES:

I. Assess indexes of insulin dynamics (insulin sensitivity and secretion) determined from an oral glucose tolerance test before and 12 weeks after a daily genistein or placebo supplement.

II. Assess measures of vascular function before and 12 weeks after a daily genistein or placebo supplement.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive genistein orally (PO) twice daily (BID) for 12 weeks.

GROUP II: Patients receive placebo PO BID for 12 weeks.

After completion of study, patients are followed up periodically.

Trial Phase Phase II

Trial Type Supportive care

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Jessica Alvarez

  • Primary ID EU3129-15
  • Secondary IDs NCI-2016-00400, IRB00086186
  • Clinicaltrials.gov ID NCT02766478