Clinical trial NCT00801242: Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
Official title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Up to 24 months after end of induction period
Secondary outcomes:
measure: Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD
timeFrame: 7 months
measure: 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
timeFrame: Up to 24 months after end of induction period
measure: Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD
timeFrame: 7 months
measure: 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
timeFrame: Up to 31 months
measure: 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
timeFrame: Up to 31 months
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
timeFrame: Up to 3 x 31 months
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
timeFrame: Up to 3 x 31 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Hospital St Jan Brugge
city: Brussels
country: Belgium
facility: Erasme Hospital, University Clinics of Brussels
city: Brussels
country: Belgium
facility: University Hospîtal St-Luc
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: AMIENS cedex 1
country: France
facility: CHU Hôpital Sud
city: BORDEAUX cedex
country: France
facility: Hôpital Pellegrin
city: CERGY PONTOISE cedex
country: France
facility: Centre Hospitalier René Dubos
city: CLERMONT-FERRAND cedex 1
country: France
facility: Hôpital Gabriel Montpied
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: LILLE cedex
country: France
facility: Hôpital Claude Huriez
city: MARSEILLE cedex 05
country: France
facility: Hôpital de la Conception
city: Montpellier
country: France
facility: Clinique Beausoleil
city: NANTES cedex 1
country: France
facility: CHU Hôtel-Dieu
city: NICE cedex 1
country: France
facility: Hôpital Pasteur
city: PARIS cedex 14
country: France
facility: Hôpital Cochin
city: PARIS cedex 20
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: CHU Pitié Salpétrière
city: Paris
country: France
facility: CHU Bichat
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Le Milétrie
city: RENNES cedex
country: France
facility: Hôpital Pontchaillou
city: STRASBOURG cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: TOULOUSE cedex 9
country: France
facility: Hôpital de Rangueil
city: Bad Schwartau
country: Germany
facility: Gemeinschaftspraxis Dres. Böhle, Rohde
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erkrath
country: Germany
facility: Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst
city: Kempen
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Kirchheim
country: Germany
facility: Gemeinschaftspraxis Dres. Rudolph, Wörner
city: Rosenheim
country: Germany
facility: Facharzt für Urologie
city: Tübingen
country: Germany
facility: Eberhard-Kars-Universität Tübingen
city: Wertingen
country: Germany
facility: Facharzt für Urologie
city: Wilhelmshaven
country: Germany
facility: Praxisgemeinschaft f. Onkologie & Urologie
city: Zwickau
country: Germany
facility: Praxis für Urologie
city: Avellino
country: Italy
facility: Azienda Ospedaliera S. Giuseppe Moscati
city: Bagno a Ripoli (FI)
country: Italy
facility: Università degli Studi di Firenze
city: Messina
country: Italy
facility: Azienda Policlinico Universitario G. Martino
city: Milano
country: Italy
facility: Ospedale S. Raffaele
city: Padova
country: Italy
facility: Università degli Studi di Padova
city: Roma
country: Italy
facility: Policlinico Univ. Agostino Gemelli
city: Almelo
country: Netherlands
facility: Twenteborg Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Kerkrade
country: Netherlands
facility: Atrium MC Kerkrade
city: Leiden
country: Netherlands
facility: Maatschap Urologie-Diaconessenhuis Leiden
city: Nijmegen
country: Netherlands
facility: UMC St.Radboud
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña (CHUAC)
city: Alcalá de Henares, Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.