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Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study

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Abstract

Purpose

In a mouse model, degarelix generated the least metabolic consequences via low follicle-stimulating hormone (FSH) levels compared with orchiectomy and leuprolide after 4 months of androgen deprivation therapy (ADT). Here, we comparatively investigated the influence of ADT with degarelix or leuprolide on the development of metabolic syndrome in patients with prostate cancer (PCa).

Methods

Patients with hormone-naive PCa were recruited. Eligible patients were randomized (1:1) to monthly degarelix or monthly leuprolide for 6 months. Key trial variables were monitored monthly. The primary endpoint was changes in fasting blood sugar (FBS). Secondary endpoints were changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels. Computed tomography was performed to measure subcutaneous and visceral fat areas before and after 6 months of ADT. Data were analyzed using the χ2 test, Student’s t test, and analysis of variance.

Results

From the 100 patients registered, 85 completed the trial (degarelix: 40 patients; leuprolide: 45 patients). Mean increases in FBS did not differ between the two arms. Similarly, there were no differences between the arms in mean increases in body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas. Follicle-stimulating hormone levels were significantly lower in the degarelix arm than in the leuprolide arm (p < 0.05).

Conclusions

Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.

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Abbreviations

ADT:

Androgen deprivation therapy

BMI:

Body mass index

DM:

Diabetes mellitus

ECOG PS:

Eastern Cooperative Oncology Group performance status

FBS:

Fasting blood sugar

FSH:

Follicle-stimulating hormone

FSHR:

Follicle-stimulating hormone receptor

GnRH:

Gonadotropin-releasing hormone

HbA1c:

Hemoglobin A1c

HDL:

High-density lipoprotein

ICO:

Index of central obesity

LDL:

Low-density lipoprotein

LH:

Luteinizing hormone

MetS:

Metabolic syndrome

PCa:

Prostate cancer

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Author information

Authors and Affiliations

  1. Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan

    Harutake Sawazaki & Daiji Araki

  2. Department of Urology, National Defense Medical College, Tokorozawa, Japan

    Yosuke Kitamura & Kota Yagi

Authors
  1. Harutake Sawazaki
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  2. Daiji Araki
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  3. Yosuke Kitamura
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  4. Kota Yagi
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Contributions

HS: project development, data collection and analysis, manuscript writing. DA: data collection and analysis, manuscript editing. YK: data collection, manuscript editing. KY: data analysis, manuscript editing.

Corresponding author

Correspondence to Harutake Sawazaki.

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Written informed consent was obtained from all participants.

Ethical standards

This study was approved by the relevant ethics committee.

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Sawazaki, H., Araki, D., Kitamura, Y. et al. Metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer: a randomized clinical study. World J Urol 38, 1465–1471 (2020). https://doi.org/10.1007/s00345-019-02937-x

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  • DOI: https://doi.org/10.1007/s00345-019-02937-x

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