Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Washington University School of Medicine
Study ID
NCT02643667
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    -Ibrutinib will be supplied by Pharmacyclics Inc.
  • Radical prostatectomy — PROCEDURE
    -Standard of care

Study Details

30-40% of patients who undergo radical prostatetecomy (RP) with curative intent for their localized prostate cancer experience relapse of their disease. Thus, improved therapeutic approaches are needed in this patient population. Enhancing the patient's anti-tumor immune response prior to surgery may improve long-term outcomes following RP

Key Dates

Start date
Jul 31, 2016
Status verified
Dec 2024
Primary completion
Apr 12, 2023
Completion
Apr 12, 2023

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Ibrutinib
    * Ibrutinib 840 mg by mouth once daily for 2 weeks. * Radical prostatectomy will be performed at least 7 days but not more than 12 days following the last scheduled dose of ibrutinib.
  • Experimental: Safety Run-In and Phase II: Ibrutinib
    * Ibrutinib 840 mg by mouth once daily for 4 weeks. * Radical prostatectomy will be performed at least 7 days but not more than 12 days following the last scheduled dose of ibrutinib

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (Phase I and Safety Run-In) [ Time Frame: Completion of DLT follow-up (2 weeks for Phase I portion and 28 days for Safety Run-In) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Francisco· San Francisco, CAWashington University School of Medicine· St Louis, MO

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