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Updated: Feb 15, 2026

A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
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A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer

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Phase II Study of Dovitinib in Patients with Castration-Resistant Prostate Cancer (KCSG-GU11-05)

Yoon Ji Choi1, Hye Sook Kim1, Se Hoon Park2

  • 1Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.

Cancer Research and Treatment
|January 16, 2018
PubMed
Abstract

Insights

Dovitinib demonstrated modest efficacy in men with metastatic castration-resistant prostate cancer (mCRPC). Chemotherapy-naïve patients and those with high VEGFR2 levels showed improved progression-free survival (PFS).

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Fibroblast growth factor (FGF) signaling pathways are implicated in prostate cancer development and progression.
  • Dovitinib is an oral inhibitor targeting VEGFR, PDGFR, and FGFR, relevant to cancer signaling.

Purpose of the Study:

  • To evaluate the efficacy and toxicity of dovitinib in patients with metastatic castration-resistant prostate cancer (mCRPC).

Main Methods:

  • A single-arm, phase II, open-label, multicenter trial involving 44 men with mCRPC.
  • Primary endpoint: 16-week progression-free survival (PFS). Secondary endpoints: overall survival (OS), toxicity, and prostate-specific antigen (PSA) response.
  • Biomarker analyses included VEGFR2, FGF23, and FGFR2 levels.

Main Results:

  • Median PFS was 3.67 months and median OS was 13.70 months.
  • Chemotherapy-naïve patients experienced significantly longer PFS (17.90 months) compared to docetaxel-treated patients (2.07 months; p=0.001).
  • Patients with high serum VEGFR2 levels (>median) had longer PFS (6.03 months) than others (1.97 months; p=0.023).
  • Common toxicities included nausea, diarrhea, fatigue, anorexia, and thrombocytopenia. Grade 3 adverse events occurred in 40.9% of patients.

Conclusions:

  • Dovitinib exhibits modest antitumor activity and manageable toxicity in men with mCRPC.
  • Chemotherapy-naïve patients represent a subgroup that may particularly benefit from dovitinib treatment.
Keywords:
BiomarkersCastration-Resistant Prostatic NeoplasmDovitinib

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