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Prostate CancerPhase 4BLADENCT03202381

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

A Phase 4 study testing Degarelix in people with Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Degarelix
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteItaly
Study dates
26 Jun 2017to Mar 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • Clinical Department of Urology, university Hospital Spedali Civili di Brescia

    Brescia, 25123

    Alessandro Antonelli, MD, +39 030 3995215, alessandro_antonelli@me.com

    Carlotta Palumbo, MD, +39 030 3995215, palumbo.carlotta@gmail.com

    Recruiting

Other trials in Italy

About this study

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

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).

Read the 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
Being tested
Degarelix
Keywords
Androgen deprivation therapy, GnRH antagonist
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

    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.

Study groups in NCT03202381
Study groupRoleWhat they receive
DegarelixExperimentalNot described
Receives: Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in fat body mass

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

    Measured: 12 months

Secondary outcomes (6)

  1. changes in bone mineral density

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

    Measured: 12 months

  2. changes in lean body mass

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

    Measured: 12 months

  3. changes in fasting serum lipids

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

    Measured: 12 months

  4. changes in bone turn-over markers

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

    Measured: 12 months

  5. changes in insulin sensitivity

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

    Measured: 12 months

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

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start26 Jun 2017
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03202381
Sponsor's protocol ID
NP2540-BLADE
Acronym
BLADE
Status last verified
Jun 2017
First submitted
12 Jun 2017
Last updated
28 Jun 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. doi: 10.1016/j.urology.2003.10.063.

    PubMed 15072892

  • Eri LM, Urdal P, Bechensteen AG. Effects of the luteinizing hormone-releasing hormone agonist leuprolide on lipoproteins, fibrinogen and plasminogen activator inhibitor in patients with benign prostatic hyperplasia. J Urol. 1995 Jul;154(1):100-4.

    PubMed 7539852

  • Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299.

    PubMed 11836291

  • Smith MR. Osteoporosis and other adverse body composition changes during androgen deprivation therapy for prostate cancer. Cancer Metastasis Rev. 2002;21(2):159-66. doi: 10.1023/a:1020840311573.

    PubMed 12465755

  • Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.

    PubMed 16434464

  • Berruti A, Dogliotti L, Terrone C, Cerutti S, Isaia G, Tarabuzzi R, Reimondo G, Mari M, Ardissone P, De Luca S, Fasolis G, Fontana D, Rossetti SR, Angeli A; Gruppo Onco Urologico Piemontese (G.O.U.P.), Rete Oncologica Piemontese. Changes in bone mineral density, lean body mass and fat content as measured by dual energy x-ray absorptiometry in patients with prostate cancer without apparent bone metastases given androgen deprivation therapy. J Urol. 2002 Jun;167(6):2361-7; discussion 2367.

    PubMed 11992038

  • Buttigliero C, Vana F, Bertaglia V, Vignani F, Fiori C, Osella G, Porpiglia F, Tucci M, Scagliotti GV, Berruti A. The fat body mass increase after adjuvant androgen deprivation therapy is predictive of prostate cancer outcome. Endocrine. 2015 Sep;50(1):223-30. doi: 10.1007/s12020-015-0525-x. Epub 2015 Jan 15.

    PubMed 25588772

  • Bergamini M, Dalla Volta A, Palumbo C, Zamboni S, Triggiani L, Zamparini M, Lagana M, Rinaudo L, Di Meo N, Caramella I, Bresciani R, Valcamonico F, Borghetti P, Guerini A, Farina D, Antonelli A, Simeone C, Mazziotti G, Berruti A. Relationship between circulating FSH levels and body composition and bone health in patients with prostate cancer who undergo androgen deprivation therapy: The BLADE study. Elife. 2024 Apr 24;13:e92655. doi: 10.7554/eLife.92655.

    PubMed 38656229

  • Palumbo C, Dalla Volta A, Zamboni S, Mazziotti G, Zamparini M, Triggiani L, Borghetti P, Maffezzoni F, Bresciani R, Rinaudo L, Valcamonico F, Farina D, Magrini SM, Antonelli A, Simeone C, Berruti A. Effect of Degarelix Administration on Bone Health in Prostate Cancer Patients Without Bone Metastases. The Blade Study. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3398-3407. doi: 10.1210/clinem/dgac489.

    PubMed 35971857

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Degarelix in people with Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in fat body mass (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03202381, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.

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BLADE Clinical Trial NCT03202381 | AzTrials