Clinical trial NCT03202381: Phase IV Study to Evaluate Bone Mineral Density in No-bone Metastatic Prostate Cancer Treated With Degarelix
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy
GnRH antagonist
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2017-06-28
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

Detailed description: Gonadotropin-releasing hormone (GnRH) agonists decrease bone mineral density (BMD) and increase fracture risk in men with prostate carcinoma. GnRH agonists also increase fat mass and decrease lean body mass. These treatment-related changes in body composition may contribute to fatigue, emotional distress, and decreased quality of life. Whereas the consequences of initial GnRH agonist on BMD and body composition are well characterized, less is known regarding the effects of GnRH antagonists. At the best of our knowledge the changes in body composition induced by Degarelix in prostate cancer patients has never been explored. Dual-energy X-ray absorptiometry (DXA) is a reliable and accurate method to determine the changes in body composition in patients with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT).

The change in body composition is a major determinant of increased morbidity and mortality induced by ADT and DXA provides the most precise measure of body composition. This study is designed to obtain explorative information on changes in bone mineral density, fat body mass and lean body mass by DXA scan after administration of Degarelix. These preliminary data compared with historical data of patients submitted to GnRH agonists could provide a rationale for a subsequent prospective randomized clinical trial.

Eligibility criteria: 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;

Primary outcomes:
measure: Changes in fat body mass
timeFrame: 12 months
Secondary outcomes:
measure: changes in bone mineral density
timeFrame: 12 months
measure: changes in lean body mass
timeFrame: 12 months
measure: changes in fasting serum lipids
timeFrame: 12 months
measure: changes in bone turn-over markers
timeFrame: 12 months
measure: changes in insulin sensitivity
timeFrame: 12 months
measure: changes in serum follicle stimulating hormone (FSH) levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Clinical Department of Urology, university Hospital Spedali Civili di Brescia
Study officials:
References:
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citation: 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.
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.