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

NCT03202381 | Unknown Phase 4

• 1 other identifier: NP2540-BLADE
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Androgen deprivation therapy; GnRH antagonist

Outcome Measures

Primary Outcomes (1)

• Changes in fat body mass

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

  12 months

Secondary Outcomes (6)

• changes in bone mineral density

  12 months

• changes in lean body mass

  12 months

• changes in fasting serum lipids

  12 months

• changes in bone turn-over markers

  12 months

• changes in insulin sensitivity

  12 months

Study Arms (1)

Degarelix

EXPERIMENTAL

Drug: Degarelix

Interventions

Degarelix DRUG

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.

Degarelix

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 15072892 BACKGROUND

• 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.

  PMID: 7539852 BACKGROUND

• 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.

  PMID: 11836291 BACKGROUND

• 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.

  PMID: 12465755 BACKGROUND

• 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.

  PMID: 16434464 BACKGROUND

• 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.

  PMID: 11992038 BACKGROUND

• 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.

  PMID: 25588772 BACKGROUND

• 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.

  PMID: 38656229 DERIVED

• 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.

  PMID: 35971857 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 28, 2017
• Study Start: June 26, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

IT (1)