Phase IV Study to Evaluate Bone Mineral Density in No-bone Metastatic Prostate Cancer Treated With Degarelix

Summary

The aim of this phase IV interventional study is to evaluate variation in bone mineral density and lean and fat body composition in patients with prostate cancer without bone metastasis, treated with Degarelix. These variations are evaluated at time 0 (before starting androgen deprivation therapy with Degarelix) and after 12 months of therapy by dual-energy X-ray absorptiometry (DXA scan).

Timeline

Start

2017-06-26

Primary completion

2019-03

Completion

2020-03

Publications

• Background Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. doi: 10.1016/j.urology.2003.10.063.
• Background Eri LM, Urdal P, Bechensteen AG. Effects of the luteinizing hormone-releasing hormone agonist leuprolide on lipoproteins, fibrinogen and plasminogen activator inhibitor in patients with benign prostatic hyperplasia. J Urol. 1995 Jul;154(1):100-4.
• Background Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299.
• Background Smith MR. Osteoporosis and other adverse body composition changes during androgen deprivation therapy for prostate cancer. Cancer Metastasis Rev. 2002;21(2):159-66. doi: 10.1023/a:1020840311573.
• Background Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.
• Background Berruti A, Dogliotti L, Terrone C, Cerutti S, Isaia G, Tarabuzzi R, Reimondo G, Mari M, Ardissone P, De Luca S, Fasolis G, Fontana D, Rossetti SR, Angeli A; Gruppo Onco Urologico Piemontese (G.O.U.P.), Rete Oncologica Piemontese. Changes in bone mineral density, lean body mass and fat content as measured by dual energy x-ray absorptiometry in patients with prostate cancer without apparent bone metastases given androgen deprivation therapy. J Urol. 2002 Jun;167(6):2361-7; discussion 2367.
• Background Buttigliero C, Vana F, Bertaglia V, Vignani F, Fiori C, Osella G, Porpiglia F, Tucci M, Scagliotti GV, Berruti A. The fat body mass increase after adjuvant androgen deprivation therapy is predictive of prostate cancer outcome. Endocrine. 2015 Sep;50(1):223-30. doi: 10.1007/s12020-015-0525-x. Epub 2015 Jan 15.
• Bergamini M, Dalla Volta A, Palumbo C, Zamboni S, Triggiani L, Zamparini M, Lagana M, Rinaudo L, Di Meo N, Caramella I, Bresciani R, Valcamonico F, Borghetti P, Guerini A, Farina D, Antonelli A, Simeone C, Mazziotti G, Berruti A. Relationship between circulating FSH levels and body composition and bone health in patients with prostate cancer who undergo androgen deprivation therapy: The BLADE study. Elife. 2024 Apr 24;13:e92655. doi: 10.7554/eLife.92655.
• Palumbo C, Dalla Volta A, Zamboni S, Mazziotti G, Zamparini M, Triggiani L, Borghetti P, Maffezzoni F, Bresciani R, Rinaudo L, Valcamonico F, Farina D, Magrini SM, Antonelli A, Simeone C, Berruti A. Effect of Degarelix Administration on Bone Health in Prostate Cancer Patients Without Bone Metastases. The Blade Study. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3398-3407. doi: 10.1210/clinem/dgac489.

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Indications