NCT03202381

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	Degarelix (Firmagon®) will be administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: * Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). * Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression.

Timeline

• Start date: 2017-06-26
• Primary completion: 2019-03-01
• Completion: 2020-03-01
• First posted: 2017-06-28
• Last updated: 2017-06-28

Locations

1 site across 1 country: Italy