Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

NCT00801242 | Completed Phase 3 Results

• 2 other identifiers: FE200486 CS292008-003931-19
• Study Type: interventional
• Target: 220
• Locations: 6 countries
• Sites: 52

Brief Summary

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment

  Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.

  Up to 24 months after end of induction period

Secondary Outcomes (7)

• Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD

  7 months

• Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment

  Up to 24 months after end of induction period

• Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD

  7 months

• Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD

  Up to 31 months

• Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD

  Up to 31 months

Study Arms (1)

Degarelix 240 mg / 80 mg

EXPERIMENTAL

Drug: Degarelix 240 mg / 80 mg

Interventions

Degarelix 240 mg / 80 mg DRUG

For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.

Also known as: FE200486, Firmagon

Degarelix 240 mg / 80 mg

Eligibility Criteria

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

You may qualify if:

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment.
• Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be \>4 ng/mL and ≤50 ng/mL.
• Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA - PSA doubling time (based on patient records at the trial site) must be \<24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL.
• Is a male patient aged 18 years or older.
• Has an Eastern Cooperative Oncology Group score of ≤2.
• Has a life expectancy of at least 24 months.

You may not qualify if:

• Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gonadotropin releasing hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit.
• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
• Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Has hypersensitivity towards any component of the investigational medicinal product.
• Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
• Has a known or suspected clinically significant liver and/or biliary disease.
• Has a history of or risk factors for Torsades de Pointes
• Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient's health or the outcome of the trial.
• Has a clinically significant disorder (other than prostate cancer) including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the investigator.
• Has severe kidney failure (creatinine clearance \<30 mL/min), based on the serum creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only valid in France).
• Has a mental incapacity or language barriers precluding adequate understanding or co operation.
• Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial.
• Has previously participated in any degarelix trial

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (52)

Hospital St Jan Brugge

Bruges, 8000, Belgium

Location

Erasme Hospital, University Clinics of Brussels

Brussels, 1070, Belgium

Location

University Hospîtal St-Luc

Brussels, 1200, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

CHU Hôpital Sud

Amiens, 80 054, France

Location

Hôpital Pellegrin

Bordeaux, 33 076, France

Location

Centre Hospitalier René Dubos

Cergy-Pontoise, 95 303, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63 003, France

Location

Hôpital Henri Mondor

Créteil, 94 000, France

Location

Hôpital Claude Huriez

Lille, 59 037, France

Location

Hôpital de la Conception

Marseille, 13 385, France

Location

Clinique Beausoleil

Montpellier, 34 070, France

Location

CHU Hôtel-Dieu

Nantes, 44 093, France

Location

Hôpital Pasteur

Nice, 06 002, France

Location

Hôpital Saint Louis

Paris, 75 010, France

Location

CHU Pitié Salpétrière

Paris, 75 013, France

Location

CHU Bichat

Paris, 75 018, France

Location

Hôpital Cochin

Paris, 75 679, France

Location

Hôpital Tenon

Paris, 75 970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69 310, France

Location

CHU Le Milétrie

Poitiers, 86 000, France

Location

Hôpital Pontchaillou

Rennes, 35 033, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67 091, France

Location

Hôpital de Rangueil

Toulouse, 31 059, France

Location

Gemeinschaftspraxis Dres. Böhle, Rohde

Bad Schwartau, 23611, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40255, Germany

Location

Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst

Erkrath, 40699, Germany

Location

Urologische Gemeinschaftspraxis

Kempen, 47906, Germany

Location

Gemeinschaftspraxis Dres. Rudolph, Wörner

Kirchheim, 73230, Germany

Location

Facharzt für Urologie

Rosenheim, 83022, Germany

Location

Eberhard-Kars-Universität Tübingen

Tübingen, 72076, Germany

Location

Facharzt für Urologie

Wertingen, 86637, Germany

Location

Praxisgemeinschaft f. Onkologie & Urologie

Wilhelmshaven, 26389, Germany

Location

Praxis für Urologie

Zwickau, 08060, Germany

Location

Azienda Ospedaliera S. Giuseppe Moscati

Avellino, 83100, Italy

Location

Università degli Studi di Firenze

Bagno A Ripoli (FI), 50011, Italy

Location

Azienda Policlinico Universitario G. Martino

Messina, 98122, Italy

Location

Ospedale S. Raffaele

Milan, 20132, Italy

Location

Università degli Studi di Padova

Padua, 35128, Italy

Location

Policlinico Univ. Agostino Gemelli

Roma, 00168, Italy

Location

Twenteborg Ziekenhuis

Almelo, 7609 PP, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Atrium MC Kerkrade

Kerkrade, 6461 AL, Netherlands

Location

Maatschap Urologie-Diaconessenhuis Leiden

Leiden, 2334 CK, Netherlands

Location

UMC St.Radboud

Nijmegen, 6525 GA, Netherlands

Location

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

Location

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, 08208, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Related Publications (2)

• Abrahamsson PA, Boccon-Gibod L, Morote J, de Jong IJ, Malmberg A, Neijber A, Albers P. Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy. Eur Urol Focus. 2017 Oct;3(4-5):470-479. doi: 10.1016/j.euf.2015.12.008. Epub 2016 Jan 22.

  PMID: 28753747 DERIVED

• Boccon-Gibod L, Albers P, Morote J, van Poppel H, de la Rosette J, Villers A, Malmberg A, Neijber A, Montorsi F. Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer. Eur Urol. 2014 Oct;66(4):655-63. doi: 10.1016/j.eururo.2014.05.037. Epub 2014 Jun 18.

  PMID: 24954791 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

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2013
• Last Updated: September 3, 2014
• Results First Posted: September 3, 2014

Record last verified: 2014-09

Locations

DE (10); NL (5); FR (20); IT (6); ES (7); BE (4)