Prostate Cancer Clinical Trial
— BLADEOfficial title:
A Pilot Phase IV Study to Evaluate Variation in Bone Mineral Density, Lean and Fat Body Mass Index Measured by Dual-energy X-ray Absorptiometry in Patients With Prostate Cancer Without Bone Metastasis Treated With Degarelix
Verified date | June 2017 |
Source | Azienda Ospedaliera Spedali Civili di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Recruiting |
Enrollment | 35 |
Est. completion date | March 2020 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - male outpatients, aged 18 or older, willing and able to provide written informed consent; - histological diagnosis of prostate carcinoma; - more than 6-month survival prospect; - no bone metastases as assessed by bone scintigraphy; - eligibility to ADT with Degarelix in the opinion of the clinical investigator. Exclusion Criteria: - patients with absolute or relative contraindication for prescription of Degarelix. In particular: - hypersensitivity towards any component of Firmagon® - patients who receive concomitant medications that might prolong the QT interval, in particular class I A (such as quinidine, procainamide, disopyramide,) or class III antiarrhythmics (such as amiodarone, sotalol, dofetilide, ibutilide) - patients with history of or risk factors for Torsades de Pointes - patients who take either methadone or moxifloxacin or antipsychotic - patients with alteration in electrolyte blood levels (such as sodium, potassium, calcium and magnesium) - patients with severe kidney and/or liver dysfunctions; - concomitant bone metabolic disease, such as Paget's disease, primary hyperparathyroidism or chronic hypercortisolism, as recorded by medical history; - renal failure (baseline serum creatinine more than 1.5 mg/dl); - prior hormonal treatment; - prior or concomitant treatment with bisphosphonates or other drugs known to affect bone metabolism (for example steroids, calcitonin); - patients participating in an interventional clinical trial in which any treatment or follow-up is mandated; |
Country | Name | City | State |
---|---|---|---|
Italy | Clinical Department of Urology, university Hospital Spedali Civili di Brescia | Brescia |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia | Ferring Pharmaceuticals |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2006 Jan 24. — View Citation
Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. — View Citation
Smith MR. Osteoporosis and other adverse body composition changes during androgen deprivation therapy for prostate cancer. Cancer Metastasis Rev. 2002;21(2):159-66. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in fat body mass | To determine changes in fat body mass after 12 months Degarelix administration. | 12 months | |
Secondary | changes in bone mineral density | to assess changes in bone mineral density after 12 months of therapy; | 12 months | |
Secondary | changes in lean body mass | to assess changes in lean body mass after 12 months of therapy; | 12 months | |
Secondary | changes in fasting serum lipids | to assess changes in fasting serum lipids after 12 months of therapy; | 12 months | |
Secondary | changes in bone turn-over markers | to assess changes in bone turn-over markers after 12 months of therapy; | 12 months | |
Secondary | changes in insulin sensitivity | to assess changes in insulin sensitivity after 12 months of therapy; | 12 months | |
Secondary | changes in serum follicle stimulating hormone (FSH) levels | to assess changes in serum FSH levels after 12 months of therapy; | 12 months |
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