CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Ibrutinib +1 moredrug
Likely dose
Ibrutinib dose not specified in eligibility or armsAI-extracted
Key inclusion· 5
  • ✓Histologically documented adenocarcinoma of the prostate
  • ✓ECOG performance status 0 or 1
  • ✓Suitable for and willing to undergo radical prostatectomy at completion of study therapy
  • ✓Available evaluable archival tumor tissue for correlative studies (immune infiltration, Btk expression) or willingness to undergo repeat prostate biopsy
Key exclusion· 12
  • ✕Neuroendocrine or small cell prostate cancer features
  • ✕Any evidence of metastatic disease
  • ✕Prior hormonal therapy (GnRH agonists/antagonists, antiandrogens, novel androgen-directed therapies, estrogens, 5-alpha reductase inhibitors, PC-SPES/PC-x)
  • ✕Prior radiation therapy for prostate cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02643667
NCT02643667Phase 2Completed
CompareCT.gov

A Phase 2 Study of Ibrutinib as Neoadjuvant Therapy in Patients With Localized Prostate Cancer

Washington University School of Medicine·interventional·Posted Dec 31, 2015·Updated Jan 8, 2025

In Brief

A Phase 2 clinical trial evaluating Ibrutinib and Radical prostatectomy for Prostate Cancer. Completed, enrolled 27 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsPharmacyclics LLC.

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 31, 2015
Enrollment StartJul 1, 2016
Primary CompletionApr 12, 2023
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 10.5 years ago

Interventions

Ibrutinibdrug

-Ibrutinib will be supplied by Pharmacyclics Inc.

Radical prostatectomyprocedure

-Standard of care