The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Hypersensitivity
Intervention: ARN-509; LHRH Agonist
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer

Summary:

      The proposed clinical trial will study the effects of 12 months of therapy with ARN-509
      alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men
      with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The
      endpoints selected reflect measurable short term effects of androgen deprivation therapy
      (ADT), including quality of life and several metabolic parameters. In addition, the relative
      effect of each treatment strategy on PSA suppression as well as testosterone recovery (and
      subsequent PSA progression) after 12 months of therapy will be evaluated.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically proven adenocarcinoma of the prostate

          -  Rising PSA after prior definitive local therapy (radical prostatectomy, external beam
             radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy
             with curative intent

          -  PSA doubling time less than or equal to 12 months

          -  No evidence of metastatic disease on imaging by whole body bone scan and computerized
             tomography (CT) or Magnetic Resonance Imaging (MRI) of the abdomen/pelvis within 6
             weeks prior to randomization

          -  Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage
             radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy

          -  Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) 6
             months prior to randomization

          -  No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse

          -  Serum testosterone > 150 ng/dL at study entry

          -  No history of seizures or medical conditions which may lower seizure threshold

        Key Exclusion Criteria:

          -  Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks
             prior to randomization

          -  Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to
             randomization

          -  Prior bilateral orchiectomy

          -  Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as
             neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation
             therapy or prostatectomy for biochemically relapsed disease is allowed provided last
             dose of ADT is greater than (>) 6 months prior to randomization and the Screening
             serum testosterone level is greater than or equal to (≥)150 ng/dL

          -  Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at
             randomization

          -  Any history of seizures or medical condition which lowers seizure threshold