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

June 27, 2017 updated by: Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Clinical Department of Urology, university Hospital Spedali Civili di Brescia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fat body mass
Time Frame: 12 months
To determine changes in fat body mass after 12 months Degarelix administration.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in bone mineral density
Time Frame: 12 months
to assess changes in bone mineral density after 12 months of therapy;
12 months
changes in lean body mass
Time Frame: 12 months
to assess changes in lean body mass after 12 months of therapy;
12 months
changes in fasting serum lipids
Time Frame: 12 months
to assess changes in fasting serum lipids after 12 months of therapy;
12 months
changes in bone turn-over markers
Time Frame: 12 months
to assess changes in bone turn-over markers after 12 months of therapy;
12 months
changes in insulin sensitivity
Time Frame: 12 months
to assess changes in insulin sensitivity after 12 months of therapy;
12 months
changes in serum follicle stimulating hormone (FSH) levels
Time Frame: 12 months
to assess changes in serum FSH levels after 12 months of therapy;
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP2540-BLADE

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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