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Study 9 of 19Degarelix literaturebiorxiv-preprint · Observational2023

Relationship between circulating FSH levels and body composition and bone health in patients with prostate cancer who undergo androgen deprivation therapy. The BLADE study

FSH levels may correlate with body composition changes in prostate cancer patients on ADT, but the clinical significance of these findings is unclear.

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1
Preclinical
16
Observational · this one
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Open-label
2
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Summary and findings

This study measured the relationship between circulating FSH levels and body composition, as well as bone health in 29 non-metastatic prostate cancer patients undergoing androgen deprivation therapy with degarelix. The evaluation included fat body mass, lean body mass, and bone mineral density at baseline and after 12 months. Results indicated correlations between FSH levels and body composition parameters after treatment.

How much of this paper we could read: full text read (0.80). We had a clear abstract, so the summary below closely tracks the paper. What this means →
r=0.64, p=0.001 for FSH and appendicular lean mass index/fat body mass ratio.2023

Abstract

The authors’ words, as biorxiv-preprint supplied them

<h4>Background</h4> Amongst its extragonadal effects, Follicle-Stimulating Hormone (FSH) has an impact on body composition and bone metabolism. Since androgen deprivation therapy (ADT) has a profound impact on circulating FSH concentrations, this hormone could potentially be implicated in the changes of fat body mass (FBM), lean body mass (LBM) and bone fragility induced by ADT. The objective of this study is to correlate FSH serum levels with body composition parameters, bone mineral density (BMD) and bone turnover markers at baseline conditions and after 12 months of ADT. <h4>Methods</h4> 29 consecutive non-metastatic prostate cancer (PC) patients were enrolled from 2017 to 2019 in a phase IV study. All patients underwent administration of the Luteinizing Hormone-Releasing Hormone antagonist degarelix. FBM, LBM and BMD were evaluated by dual-energy x-ray absorptiometry at baseline and after 12 months of ADT. FSH, alkaline phosphatase (ALP) and C-terminal telopeptide of type I collagen (CTX) were assessed at baseline and after 6 and 12 months. For outcome measurements and statistical analysis, T-test or sign test and Pearson or Spearman tests for continuous variables were used when indicated. <h4>Results</h4> At baseline conditions, a weak, non-significant, direct relationship was found between FSH serum levels and FBM at arms (r=0.36) and legs (r=0.33). Conversely, a stronger correlation was observed between FSH and total FBM (r=0.52, p=0.006), fat mass at arms (r=0.54, p=0.004) and fat mass at trunk (r=0.45, p=0.018) assessed after 12 months. On the other hand, an inverse relationship between serum FSH and appendicular lean mass index (ALMI)/FBM ratio was observed (r=0.64, p=0.001). This is an ancillary study of a prospective trial and this is the main limitation. <h4>Conclusions</h4> FSH serum levels after ADT could have an impact on body composition, in particular on fat body mass. Therefore, FSH could be a promising marker to monitor the risk of sarcopenic obesity and cardiovascular complications in PC patients undergoing ADT. <h4>Funding</h4> this research was partially funded by Ferring Pharmaceuticals. The funder had no role in design and conduct of the study, collection, management, analysis, and interpretation of the data and in preparation, review, or approval of the manuscript. <h4>Clinical trial number</h4> clinicalTrials.gov NCT03202381 , EudraCT Number 2016-004210-10.

Elsewhere in the Degarelix corpus

AEffect of neoadjuvant androgen deprivation therapy on prostate and tumor morphology prior to MRI-guided transurethral ultrasound ablation of prostate cancer.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 2026 · n=15 · PSA declined by 87% (-7.6 ng/mL; 95% CI. -9.7 to -5.7; p < 0.001)HumanBFewer Injections and Lower Drug Costs With Long-Acting GnRH Depot Formulations: A Nationwide Analysis of 2.3 Million Patient-Years in Japan.Cancer reports (Hoboken, N.J.) · 2026 · n=2276025 · Injections decreased by 21.5%, from 1,275,081 to 1,000,324.HumanBFewer Injections and Lower Drug Costs With Long-Acting GnRH Depot Formulations: A Nationwide Analysis of 2.3 Million Patient-Years in Japan.Cancer reports (Hoboken, N.J.) · 2023 · n=2276025 · Injections decreased by 21.5%, from 1,275,081 to 1,000,324.HumanBBone-related adverse events of hormonal therapy: A pharmacovigilance study based on the Food &amp; Drug Administration Adverse Event Reporting System.The Journal of international medical research · 2026 · Not reported in abstract.reviewBPeribronchial cuffing: an underrecognized pattern of prostate carcinoma metastases to the lung.BJC reports · 2023 · n=9 · 55% of patients died within a median of 5.3 months from radiographic detection.HumanBPulmonary tumor thrombotic microangiopathy associated with prostate cancer achieving over 10-year survival: a case report.International cancer conference journal · 2026 · n=1 · Not reported in abstract.Human