Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

NCT00831233 | Terminated Phase 3 Results

• 2 other identifiers: FE200486 CS282008-004338-26
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 33

Brief Summary

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

  After treatment of 12 weeks compared to Baseline

Secondary Outcomes (9)

• Change From Baseline in Total IPSS at Weeks 4 and 8

  After treatment of 4 and 8 weeks compared to Baseline

• Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit

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

• Change From Baseline in Residual Volume (Vresidual) at Each Visit

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

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

  After 12 weeks treatment compared to Baseline

• Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit

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

Study Arms (2)

Degarelix 240 mg/80 mg

EXPERIMENTAL

Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)

Drug: Degarelix

Goserelin (3.6 mg) + bicalutamide (50 mg)

ACTIVE COMPARATOR

Goserelin (3.6 mg) + bicalutamide (50 mg)

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

Degarelix 240 mg/80 mg

Goserelin DRUG

Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

Also known as: Zoladex

Goserelin (3.6 mg) + bicalutamide (50 mg)

Bicalutamide DRUG

On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 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 before any trial-related activity is performed
• Has a confirmed prostate cancer in which this type of treatment is needed.

You may not qualify if:

• Previous treatment for prostate cancer
• Previous trans-urethral resection of the prostate
• Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
• Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
• Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Hypersensitivity towards any component of the investigational product
• Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
• Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (33)

Facharztpraxis für Urologie

Bamberg, 96047, Germany

Location

Gemeinschaftspraxis

Borken, 46325, Germany

Location

Gemeinschaftspraxis

Cologne, 50667, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Euromed Clinic

Fürth, 90763, Germany

Location

Urologische Gemeinschaftspraxis

Hamburg, 22399, Germany

Location

VITURO Gesellschaft für Klinische Studien

Leipzig, 04109, Germany

Location

Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Location

Urologische Klinik Planegg

Planegg, 82152, Germany

Location

Wuppertaler Gemeinschaftspraxis

Wuppertal, 42103, Germany

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Hospital Universitario Principe de Asturias

Alcalá de Henares-Madrid, 28805, Spain

Location

Fundacion Hospital Alcorcón

Alcorcón, 28922, Spain

Location

Fundación Puigvert

Barcelona, 08025, Spain

Location

Hospital de Basurto

Bilbao (Bizkaia), 48013, Spain

Location

Hospital universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico Universitario S. Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Manacor

Manacor, 07500, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Hospital Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Virgen Macarena

Seville, 41014, Spain

Location

Hospital Xeral de Vigo

Vigo, 36204, Spain

Location

United Bristol Healthcare NHSTrust Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, FK1 5QE, United Kingdom

Location

Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

Location

Whipps Cross University Hospital

London, E11 1NR, United Kingdom

Location

The Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Royal Hallamshire Hospital, Sheffield South

Sheffield, S10 2JF, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

Related Publications (2)

• Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15.

  PMID: 23258223 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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

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

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 11, 2013
• Results First Posted: August 26, 2011

Record last verified: 2013-10

Locations

ES (13); GB (10); DE (10)