A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
Condition: Prostate Carcinoma Metastatic to the Bone; Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of the Prostate

Summary:

      The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography /
      computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response
      in metastatic bone lesions in patients who are receiving enzalutamide for
      castration-resistant prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate without
             neuroendocrine differentiation, or signet cell or small cell features;

          -  Presence of bone metastatic disease as assessed by at least two lesions on whole body
             metastable technetium-methylene diphosphonate (99mTc-MDP) bone scintigraphy;

          -  Throughout the study, ongoing androgen deprivation therapy with a luteinizing
             hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or
             surgical castration);

          -  Testosterone ≤ 1.73 nmol/L (≤ 50 ng/dL) at screening;

          -  Progressive disease on androgen deprivation therapy at screening defined as a minimum
             of two sequentially rising prostate-specific antigen (PSA) values (PSA1 < PSA2 <
             PSA3);

          -  The screening PSA (PSA3) must be ≥ 2 μg/L (≥ 2 ng/mL).

        Exclusion Criteria:

          -  Prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium Ra
             223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the
             CRPC setting for the treatment of prostate cancer or participation in a clinical trial
             of an investigational agent that inhibits the androgen receptor or androgen synthesis
             (unless treatment was placebo);

          -  Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase
             inhibitors) or biologic therapy for prostate cancer (other than LHRH analogue therapy)
             within 4 weeks before enrollment;

          -  Initiation of new treatment with denosumab, bisphosphonates, or systemic
             corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;

          -  Use of an investigational agent within 4 weeks before the screening visit;

          -  Radiation therapy to bone within 4 weeks before enrollment;

          -  Use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;

          -  Screening 99mTc-MDP bone scintigraphy showing a superscan;

          -  Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;

          -  Current or previously treated brain metastasis or active leptomeningeal disease;

          -  History of seizure any time in the past for any reason or any condition that may
             predispose to seizures.