Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

NCT ID: NCT00801242

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-07-31

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.

Detailed Description

The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA >4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 240 mg / 80 mg

Group Type: EXPERIMENTAL

Degarelix 240 mg / 80 mg

Intervention Type: 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.

Interventions

Degarelix 240 mg / 80 mg

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.

Intervention Type: DRUG

Other Intervention Names

FE200486; Firmagon

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• At time of inclusion receives concomitant medications that might prolong the QT interval.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Hospital St Jan Brugge

Bruges, , Belgium

Erasme Hospital, University Clinics of Brussels

Brussels, , Belgium

University Hospîtal St-Luc

Brussels, , Belgium

University Hospitals Leuven

Leuven, , Belgium

CHU Hôpital Sud

Amiens, , France

Hôpital Pellegrin

Bordeaux, , France

Centre Hospitalier René Dubos

Cergy-Pontoise, , France

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Hôpital Henri Mondor

Créteil, , France

Hôpital Claude Huriez

Lille, , France

Hôpital de la Conception

Marseille, , France

Clinique Beausoleil

Montpellier, , France

CHU Hôtel-Dieu

Nantes, , France

Hôpital Pasteur

Nice, , France

Hôpital Saint Louis

Paris, , France

CHU Pitié Salpétrière

Paris, , France

CHU Bichat

Paris, , France

Hôpital Cochin

Paris, , France

Hôpital Tenon

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

CHU Le Milétrie

Poitiers, , France

Hôpital Pontchaillou

Rennes, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Hôpital de Rangueil

Toulouse, , France

Gemeinschaftspraxis Dres. Böhle, Rohde

Bad Schwartau, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst

Erkrath, , Germany

Urologische Gemeinschaftspraxis

Kempen, , Germany

Gemeinschaftspraxis Dres. Rudolph, Wörner

Kirchheim, , Germany

Facharzt für Urologie

Rosenheim, , Germany

Eberhard-Kars-Universität Tübingen

Tübingen, , Germany

Facharzt für Urologie

Wertingen, , Germany

Praxisgemeinschaft f. Onkologie & Urologie

Wilhelmshaven, , Germany

Praxis für Urologie

Zwickau, , Germany

Azienda Ospedaliera S. Giuseppe Moscati

Avellino, , Italy

Università degli Studi di Firenze

Bagno A Ripoli (FI), , Italy

Azienda Policlinico Universitario G. Martino

Messina, , Italy

Ospedale S. Raffaele

Milan, , Italy

Università degli Studi di Padova

Padua, , Italy

Policlinico Univ. Agostino Gemelli

Roma, , Italy

Twenteborg Ziekenhuis

Almelo, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Atrium MC Kerkrade

Kerkrade, , Netherlands

Maatschap Urologie-Diaconessenhuis Leiden

Leiden, , Netherlands

UMC St.Radboud

Nijmegen, , Netherlands

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, , Spain

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Corporacio Sanitaria Parc Tauli

Sabadell, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Countries

Belgium; France; Germany; Italy; Netherlands; Spain

References

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.

Reference Type: DERIVED

PMID: 28753747 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24954791 (View on PubMed)

Other Identifiers

2008-003931-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FE200486 CS29

Identifier Type: -

Identifier Source: org_study_id