Study on Enzalutamide with Hormone and Radiation Therapy for High-Risk Localized Prostate Cancer

Sponsor: University of Sydney

Sponsor score: 0

ClinicalTrials ID:NCT02446444

This clinical trial is exploring the effectiveness of adding enzalutamide to standard hormone therapy and radiation treatment for men with localized prostate cancer that is at high risk of coming back.

Patient Parameters

Program Overview

The aim of this study is to find out if enzalutamide, when used with hormone therapy and radiation, can better control prostate cancer that is localized but has a high chance of returning. The hormone therapy involves using a drug that lowers testosterone levels, which is often combined with radiation therapy to treat prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that is considered high risk for returning, based on specific medical criteria like a high Gleason score or certain PSA levels.
  • Aged 18 years or older.
  • Have good bone marrow, liver, and kidney function as shown by specific blood tests.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Able to start the study treatment within 7 days of being assigned to a treatment group.
  • Willing to follow all study requirements, including attending appointments and completing questionnaires.
  • Have signed a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have prostate cancer with certain rare cell types.
  • Have cancer that has spread to lymph nodes outside the pelvis.
  • Have any condition that prevents safe use of radiation therapy.
  • Have a history of seizures or conditions that increase seizure risk.
  • Have had a recent heart attack or other serious heart problems.
  • Have evidence of cancer spread to other parts of the body.
  • Have a PSA level over 100 ng/mL.
  • Have had another cancer within the last 5 years, except for certain skin or bladder cancers.
  • Have any serious illness or infection that could affect study participation.
  • Have psychological or social issues that could interfere with the study.
  • Are sexually active and not using effective birth control.
  • Have used certain hormone therapies recently, except for specific short-term use.
  • Have had certain surgeries or treatments that affect the prostate.
  • Are participating in another clinical trial.
  • Have had major surgery recently.
  • Have digestive issues that affect the absorption of the study drug.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02115BostonMassachusetts
Beth Israel Deaconess Medical Center02215BostonMassachusetts

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