Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Dupilumab
Intervention description: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Men will be treated with dupilumab 600 mg s.q. on day 1, and then 300 mg s.q. on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. Fourteen days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: high-risk prostate cancer; localized prostate cancer; prior to prostatectomy; neoadjuvant

Summary:

      This is a single-center, single arm, open-label phase II study evaluating the safety,
      anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical
      prostatectomy.
    

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