A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer

Multicenter phase 1/2 study of neoadjuvant Ibrutinib in men with localized prostate cancer undergoing RP as their initial locally directed therapy with curative intent. To assess the immune response following neoadjuvant treatment, tissue from RP specimen will be compared to tissue from core biopsy specimen obtained prior to treatment, with each subject serving as his own control. Immune infiltration will also be compared to a reference cohort of 12 patients who had undergone RP, matched to the study population using the UCSF CAPRA-S score.


Study Type: Interventional
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Ibrutinib as Neoadjuvant Therapy in Patients With Localized Prostate Cancer
Estimated Enrollment: 36
Study Start Date: January 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Dose Level -1
- Experimental: Dose Level 1
- Experimental: Dose Level 2