Clinical trial NCT03886493 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: dupilumab
SMILES: CCO
Reason stopped: 
    low accrual due to covid-19 pandemic.
  
Eligibility criteria:

        Inclusion Criteria:

        To be eligible for this study, patients must meet all of the following criteria:

          -  Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0,
             M0) without involvement of lymph nodes, bone, or visceral organs

          -  Initial prostate biopsy is available for central pathologic review, and is confirmed
             to show at least 2 positive cores and a Gleason sum of ≥7

          -  Radical prostatectomy has been scheduled at Johns Hopkins Hospital

          -  Age ≥18 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥
             70%

          -  Adequate bone marrow, hepatic, and renal function:

               -  WBC >3,000 cells/mm3

               -  ANC >1,500 cells/mm3

               -  Hemoglobin >9.0 g/dL

               -  Platelet count >100,000 cells/mm3

               -  Serum creatinine <3 × upper limit of normal (ULN)

               -  Serum bilirubin <3 × ULN

               -  ALT <5 × ULN

               -  AST <5 × ULN

               -  Alkaline phosphatase <5 × ULN

          -  Willingness to provide written informed consent and HIPAA authorization for the
             release of personal health information, and the ability to comply with the study
             requirements (note: HIPAA authorization will be included in the informed consent)

          -  Willingness to use barrier contraception from the time of first dose of DUPILUMAB
             until the time of prostatectomy.

        Exclusion Criteria:

        To be eligible for this study, patients should not meet any of the following criteria:

          -  Presence of known lymph node involvement or distant metastases

          -  Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma,
             small cell, and neuroendocrine tumors

          -  Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for
             prostate cancer

          -  Prior immunotherapy/vaccine therapy for prostate cancer

          -  Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors

          -  Current use of systemic corticosteroids or use of corticosteroids within 4 weeks of
             enrollment (inhaled corticosteroids for asthma or COPD are permitted)

          -  Use of experimental agents for prostate cancer within the past 3 months from time of
             screening

          -  History or presence of autoimmune disease requiring systemic immunosuppression
             (including but not limited to: inflammatory bowel disease, systemic lupus
             erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis,
             hemolytic anemia, Sjögren syndrome, and sarcoidosis)

          -  History of malignancy within the last 3 years, with the exception of non-melanoma skin
             cancers and superficial bladder cancer

          -  Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or
             psychiatric illnesses that would make the patient a poor study candidate

          -  Known prior or current history of HIV and/or hepatitis B/C

          -  Significant eye disease