ArticleEuropean urology open science2021
Estetrol Cotreatment of Androgen Deprivation Therapy in Infiltrating or Metastatic, Castration-sensitive Prostate Cancer: A Randomized, Double-blind, Phase II Trial (PCombi).
Article in European urology open science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 20 citations in OpenAlex.
- Sex-specific lymphatic responses to estrogen shape atherosclerosis in high-risk mice.Frontiers in cardiovascular medicine · 2026Article
- Estetrol Inhibits the Prostate Cancer Tumor Stimulators FSH and IGF-1.Journal of clinical medicine · 2024Article
- The Loss of Estradiol by Androgen Deprivation in Prostate Cancer Patients Shows the Importance of Estrogens in Males.Journal of the Endocrine Society · 2024Review
- Estetrol: From Preclinical to Clinical Pharmacology and Advances in the Understanding of the Molecular Mechanism of Action.Drugs in R&D · 2023Review
- Testosterone suppression combined with high dose estrogen as potential treatment of SARS-CoV-2. A mini review.Heliyon · 2022Review
- Maintaining bone health by estrogen therapy in patients with advanced prostate cancer: a narrative review.Endocrine connections · 2022Review
- Estetrol Prevents Hot Flushes and Improves Quality of Life in Patients with Advanced Prostate Cancer Treated with Androgen Deprivation Therapy: The PCombi Study.European urology open science · 2022Article
- Treatment of Serious COVID-19 with Testosterone Suppression and High-dose Estrogen Therapy.European urology · 2021Article
Corrections and comments
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Authors and funding
16 authors at 12 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAndrogen deprivation therapy (ADT) for prostate cancer with luteinizing hormone-releasing hormone (LHRH) agonists can be improved.
objectiveTo assess safety, the frequency and severity of hot flushes (HFs), bone health, and antitumor effects of high-dose estetrol (HDE4) when combined with ADT. DESIGN SETTING AND
participantsA phase II, double-blind, randomized, placebo-controlled study was conducted in advanced prostate cancer patients requiring ADT (the PCombi study).
interventionPatients receiving LHRH agonist treatment were randomized 2:1 to 40 mg HDE4 ( OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Coprimary endpoints were frequency/severity of HFs and levels of total and free testosterone (T). Secondary endpoints included assessments of bone metabolism (osteocalcin and type I collagen telopeptide [CTX1]), prostate-specific antigen (PSA), and follicle-stimulating hormone (FSH). Efficacy analysis was based on the selected per-protocol (PP) population. RESULTS AND LIMITATIONS: Of 62 patients included in the study, 57 were suitable for a PP analysis (37 HDE4; 20 placebo). No E4-related serious cardiovascular adverse events occurred at 24 wk. Weekly HFs were reported by 13.5% of patients with HDE4 and 60.0% with placebo (
conclusionsHDE4 cotreatment of ADT patients with advanced prostate cancer was well tolerated, and no treatment-related cardiovascular adverse events were observed at 24 wk. HFs and bone turnover were substantially reduced. Suppression of free T, PSA, and FSH was more rapid and profound, suggesting enhanced disease control by HDE4 cotreatment. Larger and longer-lasting studies are needed to confirm the results of the study reported here. PATIENT SUMMARY: Cotreatment of androgen deprivation therapy with high-dose estetrol in advanced prostate cancer patients results in fewer occurrences of hot flushes, bone protection, and other antitumor benefits. Nipple sensitivity and gynecomastia may occur as side effects.
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