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Prostate CancerPhase 3NCT00801242

Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

A Phase 3 study testing Degarelix 240 mg / 80 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 52 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Degarelix 240 mg / 80 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
52 sitesin 6 countries
Study dates
Dec 2008to Jul 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

52 sites in 6 countries.

52 sites in 6 countries

France20 sites

  • CHU Hôpital Sud

    Amiens, 80 054

  • Hôpital Pellegrin

    Bordeaux, 33 076

  • Centre Hospitalier René Dubos

    Cergy-Pontoise, 95 303

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63 003

  • Hôpital Henri Mondor

    Créteil, 94 000

  • Hôpital Claude Huriez

    Lille, 59 037

  • Hôpital de la Conception

    Marseille, 13 385

  • Clinique Beausoleil

    Montpellier, 34 070

  • CHU Hôtel-Dieu

    Nantes, 44 093

  • Hôpital Pasteur

    Nice, 06 002

  • Hôpital Saint Louis

    Paris, 75 010

  • CHU Pitié Salpétrière

    Paris, 75 013

  • CHU Bichat

    Paris, 75 018

  • Hôpital Cochin

    Paris, 75 679

  • Hôpital Tenon

    Paris, 75 970

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69 310

  • CHU Le Milétrie

    Poitiers, 86 000

  • Hôpital Pontchaillou

    Rennes, 35 033

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67 091

  • Hôpital de Rangueil

    Toulouse, 31 059

Other trials in France

Germany10 sites

  • Gemeinschaftspraxis Dres. Böhle, Rohde

    Bad Schwartau, 23611

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40255

  • Gemeinschaftspraxis - Tagesklinik Dres. Rulf, Langhorst

    Erkrath, 40699

  • Urologische Gemeinschaftspraxis

    Kempen, 47906

  • Gemeinschaftspraxis Dres. Rudolph, Wörner

    Kirchheim, 73230

  • Facharzt für Urologie

    Rosenheim, 83022

  • Eberhard-Kars-Universität Tübingen

    Tübingen, 72076

  • Facharzt für Urologie

    Wertingen, 86637

  • Praxisgemeinschaft f. Onkologie & Urologie

    Wilhelmshaven, 26389

  • Praxis für Urologie

    Zwickau, 08060

Other trials in Germany

Spain7 sites

  • Complexo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Italy6 sites

  • Azienda Ospedaliera S. Giuseppe Moscati

    Avellino, 83100

  • Università degli Studi di Firenze

    Bagno A Ripoli (FI), 50011

  • Azienda Policlinico Universitario G. Martino

    Messina, 98122

  • Ospedale S. Raffaele

    Milan, 20132

  • Università degli Studi di Padova

    Padova, 35128

  • Policlinico Univ. Agostino Gemelli

    Roma, 00168

Other trials in Italy

Netherlands5 sites

  • Twenteborg Ziekenhuis

    Almelo, 7609 PP

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Atrium MC Kerkrade

    Kerkrade, 6461 AL

  • Maatschap Urologie-Diaconessenhuis Leiden

    Leiden, 2334 CK

  • UMC St.Radboud

    Nijmegen, 6525 GA

Other trials in Netherlands

Belgium4 sites

  • Hospital St Jan Brugge

    Bruges, 8000

  • Erasme Hospital, University Clinics of Brussels

    Brussels, 1070

  • University Hospîtal St-Luc

    Brussels, 1200

  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Read the 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
Being tested
Degarelix 240 mg / 80 mg
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Degarelix 240 mg / 80 mgDrug

    Also called FE200486, Firmagon

    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.

Study groups in NCT00801242
Study groupRoleWhat they receive
Degarelix 240 mg / 80 mgExperimentalNot described
Receives: Drug: Degarelix 240 mg / 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months after end of induction period

Secondary outcomes (7)

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

    Measured: 7 months

  2. 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

    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.

    Measured: Up to 24 months after end of induction period

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

    Measured: 7 months

  4. 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

    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).

    Measured: Up to 31 months

  5. 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

    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.

    Measured: Up to 31 months

  6. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment

    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.

    Measured: Up to 3 x 31 months

  7. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment

    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.

    Measured: Up to 3 x 31 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionJun 2012
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801242
Sponsor's protocol ID
FE200486 CS29
Other IDs
2008-003931-19, 2008
Status last verified
Sep 2014
First submitted
2 Dec 2008
Last updated
3 Sep 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 28753747

  • 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.

    PubMed 24954791

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Degarelix 240 mg / 80 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 52 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in France, Germany, Spain, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 24 months after end of induction period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801242, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.

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