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Trial · Interventional

Status unknownPhase 4Registry data

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

Short name BLADE

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
35 participants (estimated)
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Italy

Start
26 Jun 2017
Primary completion
Mar 2019 (estimated)
Completion
Mar 2020 (estimated)
First posted
28 Jun 2017
Last update posted
28 Jun 2017
Conditions
Prostate Cancer

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 4

    BLADE

    NCT03202381

    26 Jun 2017 to est. Mar 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • DegarelixDrug

Arms1

  • Experimental

    Degarelix

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in fat body mass

    Time frame · 12 months

    Registry description

    To determine changes in fat body mass after 12 months Degarelix administration.

Secondary outcomes(6)
  1. changes in bone mineral density

    Time frame · 12 months

    Registry description

    to assess changes in bone mineral density after 12 months of therapy;

  2. changes in lean body mass

    Time frame · 12 months

    Registry description

    to assess changes in lean body mass after 12 months of therapy;

  3. changes in fasting serum lipids

    Time frame · 12 months

    Registry description

    to assess changes in fasting serum lipids after 12 months of therapy;

  4. changes in bone turn-over markers

    Time frame · 12 months

    Registry description

    to assess changes in bone turn-over markers after 12 months of therapy;

  5. changes in insulin sensitivity

    Time frame · 12 months

    Registry description

    to assess changes in insulin sensitivity after 12 months of therapy;

  6. changes in serum follicle stimulating hormone (FSH) levels

    Time frame · 12 months

    Registry description

    to assess changes in serum FSH levels after 12 months of therapy;

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2024

Relationship between circulating FSH levels and body composition and bone health in patients with prostate cancer who undergo androgen deprivation therapy: The BLADE study.

Bergamini et al. 2024eLifecited by 7

PMID 38656229PMC11042799DOI 10.7554/elife.92655PUB-38656229

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 1995

11 results

Effects of the luteinizing hormone-releasing hormone agonist leuprolide on lipoproteins, fibrinogen and plasminogen activator inhibitor in patients with benign prostatic hyperplasia.

Eri et al. 1995The Journal of urologycited by 64

PMID 7539852DOI 10.1016/s0022-5347(01)67239-2PUB-07539852

Full text at the publisher11 results

More studies

3 studies on this page

PubMed tag: none · 2022

Effect of Degarelix Administration on Bone Health in Prostate Cancer Patients Without Bone Metastases. The Blade Study.

Palumbo et al. 2022The Journal of clinical endocrinology and metabolismcited by 12

PMID 35971857DOI 10.1210/clinem/dgac489PUB-35971857

Rights unknown
Source link

PubMed tag: none · 2006

Insulin sensitivity during combined androgen blockade for prostate cancer.

Smith et al. 2006The Journal of clinical endocrinology and metabolismcited by 348

PMID 16434464DOI 10.1210/jc.2005-2507PUB-16434464

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2002

Changes in body composition during androgen deprivation therapy for prostate cancer.

Smith et al. 2002The Journal of clinical endocrinology and metabolismcited by 497

PMID 11836291DOI 10.1210/jcem.87.2.8299PUB-11836291

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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;

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