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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Arm Intervention/treatment
Experimental: Degarelix 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.





Primary Outcome Measures :
  1. Changes in fat body mass [ Time Frame: 12 months ]
    To determine changes in fat body mass after 12 months Degarelix administration.


Secondary Outcome Measures :
  1. changes in bone mineral density [ Time Frame: 12 months ]
    to assess changes in bone mineral density after 12 months of therapy;

  2. changes in lean body mass [ Time Frame: 12 months ]
    to assess changes in lean body mass after 12 months of therapy;

  3. changes in fasting serum lipids [ Time Frame: 12 months ]
    to assess changes in fasting serum lipids after 12 months of therapy;

  4. changes in bone turn-over markers [ Time Frame: 12 months ]
    to assess changes in bone turn-over markers after 12 months of therapy;

  5. changes in insulin sensitivity [ Time Frame: 12 months ]
    to assess changes in insulin sensitivity after 12 months of therapy;

  6. changes in serum follicle stimulating hormone (FSH) levels [ Time Frame: 12 months ]
    to assess changes in serum FSH levels after 12 months of therapy;



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

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


Locations
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Italy
Clinical Department of Urology, university Hospital Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Alessandro Antonelli, MD    +39 030 3995215    alessandro_antonelli@me.com   
Contact: Carlotta Palumbo, MD    +39 030 3995215    palumbo.carlotta@gmail.com   
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Ferring Pharmaceuticals
Publications:

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Responsible Party: Alessandro Antonelli, Principal Investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03202381    
Other Study ID Numbers: NP2540-BLADE
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:
Androgen deprivation therapy
GnRH antagonist
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases