A Study to Determine if Enzalutamide can Delay Prostate Cancer Progression Verses Active Surveillence

What we are studying

You are being asked to take part in this research study because you have early stage (localized) prostate cancer and are undergoing active surveillance (being observed over time to see if your prostate cancer changes). The purpose of this study is to see if enzalutamide, an approved product for treating prostate cancer in advanced stages, can delay the progression of early stage prostate cancer. The information collected in this study is necessary to find out whether the treatment tested is effective and safe. The information about you will be kept anonymous. Information may be used for seeking approval from the regulatory authorities to market the medicine for treating prostate cancer. It may also be used in reports of the study or for scientific presentations. Astellas may also use the information from this study for future medical research.

Who is Eligible

  • Genders:
    • Men
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Ability to swallow study medication
  • Must use contraception if sexually active male
  • Cannot donate sperm
  • Could not have prior radiotherapy
  • Surgery
  • Chemotherapy
  • Or hormonal therapy for prostate cancer
  • Cannot have history of seizures.

What is involved

  • Physical examination
  • Vital signs
  • 12-Lead ECG
  • Echocardiogram
  • Blood draws
  • Digital Rectal Examination
  • Urine biomarker analysis
  • Transrectal ultrasound-guided prostate biopsy
  • Questionnaires

Compensation

None

Contact Information

Study Coordinator
Chase Thurman
Email
[email protected]
Phone
-9010
Principal Investigator
K.C. Balaji, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.