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

Prostate Cancer Clinical Trial

— BLADE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202381
• Other study ID #: NP2540-BLADE
• Status: Recruiting
• Phase: Phase 4
• First received: June 12, 2017
• Last updated: June 27, 2017
• Start date: June 26, 2017
• Est. completion date: March 2020

Study information

• Verified date: June 2017
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Clinical Department of Urology, university Hospital Spedali Civili di Brescia	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia	Ferring Pharmaceuticals

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jan 24. — View Citation

Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. — View Citation

Smith MR. Osteoporosis and other adverse body composition changes during androgen deprivation therapy for prostate cancer. Cancer Metastasis Rev. 2002;21(2):159-66. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fat body mass	To determine changes in fat body mass after 12 months Degarelix administration.	12 months
Secondary	changes in bone mineral density	to assess changes in bone mineral density after 12 months of therapy;	12 months
Secondary	changes in lean body mass	to assess changes in lean body mass after 12 months of therapy;	12 months
Secondary	changes in fasting serum lipids	to assess changes in fasting serum lipids after 12 months of therapy;	12 months
Secondary	changes in bone turn-over markers	to assess changes in bone turn-over markers after 12 months of therapy;	12 months
Secondary	changes in insulin sensitivity	to assess changes in insulin sensitivity after 12 months of therapy;	12 months
Secondary	changes in serum follicle stimulating hormone (FSH) levels	to assess changes in serum FSH levels after 12 months of therapy;	12 months