Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03886493

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov