Phase IV Study to Evaluate Bone Mineral Density in No-bone Metastatic Prostate Cancer Treated With Degarelix (BLADE)
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|ClinicalTrials.gov Identifier: NCT03202381|
Recruitment Status : Unknown
Verified June 2017 by Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.
Recruitment status was: Recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Degarelix||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
Degarelix (Firmagon®) will be administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule:
Treatment will be continued till clinically indicated or till disease progression.
- Changes in fat body mass [ Time Frame: 12 months ]To determine changes in fat body mass after 12 months Degarelix administration.
- changes in bone mineral density [ Time Frame: 12 months ]to assess changes in bone mineral density after 12 months of therapy;
- changes in lean body mass [ Time Frame: 12 months ]to assess changes in lean body mass after 12 months of therapy;
- changes in fasting serum lipids [ Time Frame: 12 months ]to assess changes in fasting serum lipids after 12 months of therapy;
- changes in bone turn-over markers [ Time Frame: 12 months ]to assess changes in bone turn-over markers after 12 months of therapy;
- changes in insulin sensitivity [ Time Frame: 12 months ]to assess changes in insulin sensitivity after 12 months of therapy;
- changes in serum follicle stimulating hormone (FSH) levels [ Time Frame: 12 months ]to assess changes in serum FSH levels after 12 months of therapy;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202381
|Clinical Department of Urology, university Hospital Spedali Civili di Brescia||Recruiting|
|Brescia, Italy, 25123|
|Contact: Alessandro Antonelli, MD +39 030 3995215 email@example.com|
|Contact: Carlotta Palumbo, MD +39 030 3995215 firstname.lastname@example.org|