Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

September 2, 2014 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Hospital St Jan Brugge
      • Brussels, Belgium, 1070
        • Erasme Hospital, University Clinics of Brussels
      • Brussels, Belgium, 1200
        • University Hospîtal St-Luc
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
  • France
      • AMIENS cedex 1, France, 80 054
        • CHU Hopital Sud
      • BORDEAUX cedex, France, 33 076
        • Hôpital Pellegrin
      • CERGY PONTOISE cedex, France, 95 303
        • Centre Hospitalier Rene Dubos
      • CLERMONT-FERRAND cedex 1, France, 63 003
        • Hopital Gabriel Montpied
      • Creteil, France, 94 000
        • Hopital Henri Mondor
      • LILLE cedex, France, 59 037
        • Hopital Claude Huriez
      • MARSEILLE cedex 05, France, 13 385
        • Hopital de la Conception
      • Montpellier, France, 34 070
        • Clinique Beausoleil
      • NANTES cedex 1, France, 44 093
        • CHU Hôtel-Dieu
      • NICE cedex 1, France, 06 002
        • Hôpital Pasteur
      • PARIS cedex 14, France, 75 679
        • Hopital Cochin
      • PARIS cedex 20, France, 75 970
        • Hôpital Tenon
      • Paris, France, 75 010
        • Hopital Saint Louis
      • Paris, France, 75 013
        • CHU Pitie Salpetriere
      • Paris, France, 75 018
        • CHU Bichat
      • Pierre Benite, France, 69 310
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86 000
        • CHU Le Milétrie
      • RENNES cedex, France, 35 033
        • Hopital Pontchaillou
      • STRASBOURG cedex, France, 67 091
        • Hopitaux Universitaires de Strasbourg
      • TOULOUSE cedex 9, France, 31 059
        • Hôpital de Rangueil
  • Germany
      • Bad Schwartau, Germany, 23611
        • Gemeinschaftspraxis Dres. Böhle, Rohde
      • Düsseldorf, Germany, 40255
        • Universitätsklinikum Düsseldorf
      • Erkrath, Germany, 40699
        • Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst
      • Kempen, Germany, 47906
        • Urologische Gemeinschaftspraxis
      • Kirchheim, Germany, 73230
        • Gemeinschaftspraxis Dres. Rudolph, Wörner
      • Rosenheim, Germany, 83022
        • Facharzt für Urologie
      • Tübingen, Germany, 72076
        • Eberhard-Kars-Universität Tübingen
      • Wertingen, Germany, 86637
        • Facharzt für Urologie
      • Wilhelmshaven, Germany, 26389
        • Praxisgemeinschaft f. Onkologie & Urologie
      • Zwickau, Germany, 08060
        • Praxis für Urologie
  • Italy
      • Avellino, Italy, 83100
        • Azienda Ospedaliera S. Giuseppe Moscati
      • Bagno a Ripoli (FI), Italy, 50011
        • Università degli studi di Firenze
      • Messina, Italy, 98122
        • Azienda Policlinico Universitario G. Martino
      • Milano, Italy, 20132
        • Ospedale S. Raffaele
      • Padova, Italy, 35128
        • Università degli studi di Padova
      • Roma, Italy, 00168
        • Policlinico Univ. Agostino Gemelli
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Twenteborg Ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Kerkrade, Netherlands, 6461 AL
        • Atrium MC Kerkrade
      • Leiden, Netherlands, 2334 CK
        • Maatschap Urologie-Diaconessenhuis Leiden
      • Nijmegen, Netherlands, 6525 GA
        • UMC St.Radboud
  • Spain
      • A Coruña, Spain, 15006
        • Complexo Hospitalario Universitario A Coruña (CHUAC)
      • Alcalá de Henares, Madrid, Spain, 28805
        • Hospital Universitario Príncipe de Asturias
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Sabadell, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Degarelix 240 mg / 80 mg
Drug: 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.
Other Names:
  • Firmagon
  • FE200486

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Up to 24 months after end of induction period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD
Time Frame: 7 months
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
Time Frame: 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.
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
Time Frame: 7 months
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
Time Frame: 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).
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
Time Frame: 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.
Up to 31 months
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Time Frame: 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.
Up to 3 x 31 months
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
Time Frame: 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.
Up to 3 x 31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FE200486 CS29
  • 2008-003931-19 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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