Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
- Registration Number
- NCT00801242
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 220
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Degarelix 240 mg / 80 mg Degarelix 240 mg / 80 mg -
- Primary Outcome Measures
Name Time Method 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 Up to 24 months after end of induction period 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment Up to 3 x 31 months This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.
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 Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment Up to 3 x 31 months This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.
Percentage Change in PSA Serum Levels From Baseline to 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 The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
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 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 The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.
Trial Locations
- Locations (51)
Clinique Beausoleil
🇫🇷Montpellier, France
CHU Hôtel-Dieu
🇫🇷NANTES cedex 1, France
Hôpital Tenon
🇫🇷PARIS cedex 20, France
Hôpital Pontchaillou
🇫🇷RENNES cedex, France
Policlinico Univ. Agostino Gemelli
🇮🇹Roma, Italy
Università degli Studi di Firenze
🇮🇹Bagno a Ripoli (FI), Italy
Università degli Studi di Padova
🇮🇹Padova, Italy
CHU Hôpital Sud
🇫🇷AMIENS cedex 1, France
Hôpitaux Universitaires de Strasbourg
🇫🇷STRASBOURG cedex, France
Hôpital de Rangueil
🇫🇷TOULOUSE cedex 9, France
Facharzt für Urologie
🇩🇪Wertingen, Germany
Eberhard-Kars-Universität Tübingen
🇩🇪Tübingen, Germany
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Azienda Ospedaliera S. Giuseppe Moscati
🇮🇹Avellino, Italy
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
Hôpital Pasteur
🇫🇷NICE cedex 1, France
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Spain
Hospital Universitario Principe de Asturias
🇪🇸Alcalá de Henares, Madrid, Spain
Gemeinschaftspraxis Dres. Böhle, Rohde
🇩🇪Bad Schwartau, Germany
Hospital St Jan Brugge
🇧🇪Brugge, Belgium
Hôpital Saint Louis
🇫🇷Paris, France
Azienda Policlinico Universitario G. Martino
🇮🇹Messina, Italy
Hôpital Pellegrin
🇫🇷BORDEAUX cedex, France
Hôpital Cochin
🇫🇷PARIS cedex 14, France
CHU Bichat
🇫🇷Paris, France
Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst
🇩🇪Erkrath, Germany
Gemeinschaftspraxis Dres. Rudolph, Wörner
🇩🇪Kirchheim, Germany
Praxisgemeinschaft f. Onkologie & Urologie
🇩🇪Wilhelmshaven, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Ospedale S. Raffaele
🇮🇹Milano, Italy
CHU Le Milétrie
🇫🇷Poitiers, France
Complexo Hospitalario Universitario A Coruña (CHUAC)
🇪🇸A Coruña, Spain
CHU Pitié Salpétrière
🇫🇷Paris, France
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Urologische Gemeinschaftspraxis
🇩🇪Kempen, Germany
Twenteborg Ziekenhuis
🇳🇱Almelo, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
UMC St.Radboud
🇳🇱Nijmegen, Netherlands
Erasme Hospital, University Clinics of Brussels
🇧🇪Brussels, Belgium
University Hospîtal St-Luc
🇧🇪Brussels, Belgium
Hôpital Henri Mondor
🇫🇷Creteil, France
Hôpital Claude Huriez
🇫🇷LILLE cedex, France
Centre Hospitalier René Dubos
🇫🇷CERGY PONTOISE cedex, France
Hôpital de la Conception
🇫🇷MARSEILLE cedex 05, France
Hôpital Gabriel Montpied
🇫🇷CLERMONT-FERRAND cedex 1, France
Praxis für Urologie
🇩🇪Zwickau, Germany
University Hospitals Leuven
🇧🇪Leuven, Belgium
Atrium MC Kerkrade
🇳🇱Kerkrade, Netherlands
Maatschap Urologie-Diaconessenhuis Leiden
🇳🇱Leiden, Netherlands