Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02064582

Sponsor: University of Texas Southwestern Medical Center

Phase: Phase 2


  • Age: minimum 18 Years maximum 90 Years
  • Gender: Male

Inclusion Criteria:

  • histologically proven adenocarcinoma of the prostate within 6 months of screening
  • Eastern Cooperative Oncology Group(ECOG) score 0-2
  • adequate organ and and blood marrow function
  • must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
  • patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
  • men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception

Exclusion Criteria:

  • prior treatment with agents known to have endocrine effects on prostate cancer
  • treatment with corticosteroids within 4 weeks of enrollment
  • treatment with androgens within 6 months of enrollment
  • may not be receiving any other investigational agents
  • Prostate specific antigen greater than 160ng/dL
  • history of malignancy( other than non-melanoma skin cancer) within 5 years
  • uncontrolled intercurrent illness
  • cardiovascular event within 6 months of enrollment
  • seizure or seizure disorder history
  • contraindications to MRI- pacemakers, clips, etc

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