Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer

  • End date
    Mar 31, 2022
  • participants needed
  • sponsor
    Washington University School of Medicine
Updated on 8 May 2021
platelet count
biopsy of prostate
adenocarcinoma of prostate


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.

Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Ibrutinib, Radical Prostatectomy, Blood samples for PSA and immune assays
Clinical Study IdentifierNCT02643667
SponsorWashington University School of Medicine
Last Modified on8 May 2021


Yes No Not Sure

Inclusion Criteria

years of age or older
ECOG performance status 0 or 1
Histologically documented adenocarcinoma of the prostate
Patients must be suitable for and willing to undergo a radical prostatectomy at the completion of study therapy
Adequate bone marrow function, defined as
WBC >2,500 cells/mm3
ANC >1,500 cells/mm3
Hemoglobin >9 mg/dL
Platelet count >100,000 cells/mm3
Adequate renal function, defined as serum creatinine <2 mg/dL or CrCl >30 mL/min
Adequate liver function, defined as
AST and ALT <2.5x institutional ULN
Serum bilirubin <1.5x institutional ULN
Adequate coagulation function, defined as normal PT/INR and PTT
Ability to understand and willingness to sign a written informed consent document
Available evaluable archival tumor tissue for correlative studies including assessment of immune infiltration and Btk expression is required. If archival tissue is unavailable, patients must be willing to undergo repeat prostate biopsy. Tissue is considered sufficient for correlative endpoint analyses if they are obtained from at least 2 prostate cores and consist of at least 15 unstained slides from the largest tumor volume and/or highest Gleason score. The availability of archival tissue or consent for repeat prostate biopsy is required for study eligibility; determination of tissue sufficiency is not required for study eligibility
The effects of ibrutinib on the developing human fetus is unknown. Men treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of the study participation, and for 3 months after completion of treatment

Exclusion Criteria

Patients with neuroendocrine or small cell features are not eligible
Any evidence of metastatic disease. Pre-operative staging will be undertaken per urologic standard of care
Any prior use of hormonal therapy, including
GNRH agonists or GNRH antagonists (e.g., leuprorelin, degarelix)
Antiandrogens (e.g., bicalutamide, flutamide, nilutamide)
Novel androgen-directed therapies (e.g., abiraterone, enzalutamide)
Any estrogen containing compounds
-alpha reductase inhibitors (e.g., finasteride, dutasteride)
PC-SPES or PC-x products. Other herbal therapies or supplements will be considered by the Principle Investigator on a case by case basis based on their potential for hormonal or anti-cancer therapies
Chemotherapy 21 days prior to first administration of study treatment and/or monoclonal antibody 6 weeks prior to first administration of study treatment
Prior radiation therapy for prostate cancer
Prior exposure to BTK inhibitors
Prior investigational therapy for prostate cancer
Patients may not receive any other concurrent investigational agents while on study
Use of systemic steroid therapy within 28 days of study screening. Patients on inhaled or topical steroids are eligible
Concurrent systemic immunosuppressive therapy within 21 days of the first dose of study drug
Major surgery requiring the use of general anesthetic within 4 weeks of study enrollment
HIV, active hepatitis B (HBV) or active hepatitis C (HCV)
Patients with past HBV infection or resolved HBV infection, defined as the presence of hepatitis B core antibody (HBc Ab) and absence of hepatitis B surface antigen (HBsAg) are eligible. HBV DNA must be obtained in these patients prior to day 1 of ibrutinib therapy, but detection of HBV DNA in these patients will not exclude study participation
Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Inability to swallow capsules or presence of malabsorption syndromes, disease significantly affecting gastrointestinal function, history of resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete small obstruction
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Function Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening
Uncontrolled concurrent illness, or any underlying medical condition, which in the Principal Investigator's opinion will make the administration of ibrutinib hazardous or obscure the interpretation of adverse events
Recent infection requiring systemic treatment that was completed within 14 days prior to the first dose of study drug
Concurrent active malignancy other than non-melanoma skin cancers. Patients are considered to be free of active malignancy if they have completed curative therapy and have a <30% risk of relapse
History of congenital bleeding diathesis
Known bleeding disorders (e.g. von Willebrand's disease or hemophilia)
Concomitant use of anticoagulants including warfarin, other Vitamin K antagonists, and enoxaparin
Subjects who received a strong or moderate cytochrome P450 (CYP) 3A4 inhibitor within 7 days prior to the first dose of ibrutinib or patients who require treatment with a strong or moderate cytochrome P450 (CYP) 3A inhibitor
Vaccination with live, attenuated vaccines within 4 weeks of first dose of study drug
Patients on anti-platelet agents including clopidogrel and glycoprotein IIb/IIIa inhibitors. Aspirin is allowed, but should be held before surgery according to standard practices
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child-Pugh classification
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE v 4.03 grade 0 or 1 or to the levels dictated in the eligibility criteria with the exception of alopecia
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