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

Sawazaki, Harutake; Araki, Daisuke; Kitamura, Yosuke; Yagi, Kota

doi:10.1007/s00345-019-02937-x

Cited by 9 publications

(3 citation statements)

References 11 publications

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“…In GnRH‐suppressed young healthy men, no impact of a 5‐week treatment with rFSH on a standard set of metabolic, hematological, and inflammatory markers was found. Our results support previous studies on human subjects reporting no effects of FSH on metabolic parameters 29 . They are however in contrast to studies on men undergoing androgen deprivation therapy for prostate cancer, who seem to be at risk for CVD, metabolic syndrome, bone deprivation, and cognitive impairment, which are processes in which FSH may play a role 19 .…”

Section: Discussionsupporting

confidence: 86%

“…Our results support previous studies on human subjects reporting no effects of FSH on metabolic parameters. 29 They are however in contrast to studies on men undergoing androgen deprivation therapy for prostate cancer, who seem to be at risk for CVD, metabolic syndrome, bone deprivation, and cognitive impairment, which are processes in which FSH may play a role. 19 In this context, the crucial difference between our results and those on men with prostate cancer may be found in the age of the study populations.…”

Section: Discussionmentioning

confidence: 94%

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Non‐reproductive effects of follicle‐stimulating hormone in young men

et al. 2023

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Objective: Follicle-stimulating hormone (FSH) receptor expression has been reported in many extra-gonadal tissues, raising the question of non-reproductive effects of FSH.Because of increasing usage of FSH in treatment of male infertility, deeper knowledge of possible harmful off-target effects of FSH is warranted. Methods:In total, 33 healthy young men (mean age 30 years) were included in the study. All received an s.c. injection of gonadotropin-releasing hormone (GnRH) antagonist and n = 16 were randomized to 300 IU recombinant FSH (300 IE 3 times/week) for 5 weeks at first visit (V1) whereas n = 17 served as controls. Blood samples were taken at (V1), after 3 weeks (V2), and after 5 weeks (V3), when the study ended. At V2, all subjects received 1000 mg testosterone undecanoate i.m. A standard set of bio-and inflammatory markers were compared between the groups using the Mann-Whitney test adjusted for multiple testing. Results:As compared to controls, the FSH treated men had higher SHBG and albumin concentrations at V2 (p = 0.024 and 0.027, respectively), and lower levels of alanine aminotransferase (p = 0.026) and magnesium (p = 0.028) at V3. However, none of the results remained statistically significant after Bonferroni correction (p > 0.0011).Conclusions: FSH had no significant effects on non-reproductive organs when given in standard therapeutic doses to young men for 5 weeks. Therefore, the FSH treatment can be considered safe in otherwise healthy young men, constituting candidates for the infertility treatment with FSH.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 94%

Non‐reproductive effects of follicle‐stimulating hormone in young men

et al. 2023

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“…In the male, FSH is the prime inducer of proliferation of spermatogonia [24]. FSH levels are suppressed by ADT alone [21] and by ADT combined with an ARSI [25], or by tE2 only [26]. The almost complete suppression of FSH (97.8%) in all patients co-treated with E4 is therefore a significant anti-tumor effect just like the significantly enhanced suppression of the mitogen IGF-1.…”

Section: Discussionmentioning

confidence: 99%

The Anti-Tumor Effects of the Fetal Estrogen Estetrol in Advanced Prostate Cancer

Coelingh Bennink,

Roos,

van Moorselaar

et al. 2024

Preprint

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Background: Co-treatment of the fetal estrogen estetrol (E4) with androgen deprivation therapy (ADT) for advanced prostate cancer (PCa) may further inhibit endocrine PCa tumor stimulators including testosterone (T), prostate-specific antigen (PSA), follicle-stimulating hormone (FSH), and insulin-like growth factor-1 (IGF-1). Methods: A Phase II, double-blind, randomized, placebo-controlled study in advanced PCa patients requiring ADT (the PCombi study) was conducted to assess the effect of E4 co-treatment with LHRH agonist ADT on total T, free T, PSA, FSH, and IGF-1. Patients starting ADT were randomized 2:1 to 40 mg E4 (n=41) or placebo (n=21) for 24 weeks. Analyses were performed on the per-protocol population (PP), using the Wilcoxon-rank sum and the Kruskal-Wallis test. Results: The PP population consisted of 57 patients (37 ADT+E4; 20 ADT+placebo). All individual data of the four endocrine tumor stimulators are presented in figures in the paper and in supplementary tables, showing that E4 co-treatment almost completely suppressed FSH levels in all patients, on average by 98% versus 37% in the placebo group (p

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