Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

NCT00884273 | Completed Phase 3 Results

• 2 other identifiers: FE200486 CS312008-008604-40
• Study Type: interventional
• Target: 182
• Locations: 8 countries
• Sites: 46

Brief Summary

This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)

  TRUS is a method of measuring the size of the prostate.

  After treatment of 12 weeks compared to Baseline

• Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)

  TRUS is a method of measuring the size of the prostate.

  After treatment of 12 weeks compared to Baseline

Secondary Outcomes (8)

• Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8

  After treatment of 4 and 8 weeks compared to Baseline

• Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12

  After treatment of 4, 8, and 12 weeks compared to Baseline

• Change in Serum Testosterone Levels During the Study

  At 4, 8, and 12 weeks compared to baseline.

• Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study

  At 4, 8, and 12 weeks compared to baseline.

• Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit

  After treatment of 4, 8, and 12 weeks compared to Baseline

Study Arms (2)

Degarelix 240 mg/80 mg

EXPERIMENTAL

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.

Drug: Degarelix

Goserelin (3.6 mg) + bicalutamide (50 mg)

ACTIVE COMPARATOR

Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.

Drug: Goserelin; Drug: Bicalutamide

Interventions

Degarelix DRUG

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.

Also known as: FE200486, FIRMAGON

Degarelix 240 mg/80 mg

Goserelin DRUG

Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.

Also known as: ZOLADEX

Goserelin (3.6 mg) + bicalutamide (50 mg)

Bicalutamide DRUG

On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.

Also known as: CASODEX

Goserelin (3.6 mg) + bicalutamide (50 mg)

Eligibility Criteria

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

You may qualify if:

• Patient has given written informed consent
• Patient is 18 years or older
• Patient has histologically confirmed prostate cancer
• Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL
• The prostate size is \>30 cubic centimetres (cc), measured by TRUS
• Patient must be able to undergo transrectal examinations
• Patient has an estimated life expectancy of at least 12 months

You may not qualify if:

• Any previous treatments for prostate cancer
• Previous trans-urethral resection of the prostate (TURP)
• Is not considered a candidate for medical castration
• Use of urethral catheter
• Is currently treated with a 5-alpha reductase inhibitor
• Is currently treated with an alpha-adrenoceptor antagonist
• Treatment with botulinum toxin A (Botox)
• Require radiotherapy during the trial
• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
• Hypersensitivity towards any component of the investigational products or excipients
• Previous history or presence of another malignancy
• A clinically significant disorder
• A corrected QT interval over 450 msec
• Mental incapacity or language barrier precluding adequate understanding or co-operation
• Receipt of an investigational drug within the last 28 days proceeding screening

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (46)

Hospital St Jan Brugge

Bruges, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

St. Elisabethziekenhuis

Turnhout, Belgium

Location

Aalborg Sygehus syd

Aalborg, Denmark

Location

Århus Universitetshospital, Skejby

Aarhus, Denmark

Location

Herlev Hospital

Ballerup Municipality, Denmark

Location

Regionhospitalet Holstebro

Holstebro, Denmark

Location

Sygehus Syd, Næstved Sygehus

Næstved, Denmark

Location

Roskilde Sygehus

Roskilde, Denmark

Location

HYKS/kirurgian klin./urologia

Helsinki, Finland

Location

KYS/kirurgian klin (Kuopio)

Kuopio, Finland

Location

OYS/kirurgian klinik

Oulu, Finland

Location

TAYS/kirurgian klinik

Tampere, Finland

Location

Azienda Ospedaliero Universitaria Ospedali riuniti

Ancona, Italy

Location

Azienda Ospedaliera S. Giuseppe Moscaaati

Avellino, Italy

Location

Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna

Bologna, Italy

Location

U.O. Di Urologia - Spedali Civili di Brescia

Brescia, Italy

Location

Clinica Urologica 1 Universita. Firensa

Florence, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Location

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Milan, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo

Palermo, Italy

Location

Clinica Urologica - Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma

Roma, Italy

Location

S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette

Torino, Italy

Location

Moelv spesialistsenter

Moelv, Norway

Location

Aker Universitetssykehus HF

Oslo, Norway

Location

Det Norske Radiumhospitalet HF

Oslo, Norway

Location

St Olavs Hospital HF

Trondheim, Norway

Location

Hospital Fernando da Fonseca

Amadora, Portugal

Location

Hospitais Universidade Coimbra

Coimbra, Portugal

Location

Centro Hospitalar Lisboa Norte, Hospital Santa Maria

Lisbon, Portugal

Location

Hospital S.João

Porto, Portugal

Location

Investigational site

Gothenburg, Sweden

Location

SU/Sahlgrenska

Gothenburg, Sweden

Location

Helsingborgs Lasarett

Helsingborg, Sweden

Location

Universitetssjukhuset MAS

Malmo, Sweden

Location

Södertälje Sjukhus

Södertälje, Sweden

Location

Uppsala/Akademiska sjukhuset

Uppsala, Sweden

Location

Cerrahpasa Faculty of Medicine, Kocamustafapasa

Istanbul, Turkey (Türkiye)

Location

Istanbul University Faculty of Medicine, ÇAPA

Istanbul, Turkey (Türkiye)

Location

Marmara University Faculty of Medicine, Altunizade

Istanbul, Turkey (Türkiye)

Location

Ankara University Faculty of Medicine

Sıhhıye - Ankara, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine

Sıhhıye - Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Axcrona K, Aaltomaa S, da Silva CM, Ozen H, Damber JE, Tanko LB, Colli E, Klarskov P. Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide. BJU Int. 2012 Dec;110(11):1721-8. doi: 10.1111/j.1464-410X.2012.11107.x. Epub 2012 Apr 13.

  PMID: 22500884 RESULT

• Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

  PMID: 34350976 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; Goserelin; bicalutamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Ferring Pharmaceuticals
• Organization: Clinical Development Support

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 13, 2013
• Results First Posted: April 11, 2012

Record last verified: 2013-10

Locations

PT (4); IT (13); DK (6); SE (6); BE (4); FI (4); TU (5); NO (4)