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Prostate CancerPhase 3NCT00831233

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

A Phase 3 study testing Degarelix, Goserelin and Bicalutamide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 33 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. 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, Goserelin and Bicalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
33 sitesin 3 countries
Study dates
Apr 2009to Jul 2010
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

  • Patient has given written informed consent before any trial-related activity is performed
  • Has a confirmed prostate cancer in which this type of treatment is needed.

Who cannot join

  • Previous treatment for prostate cancer
  • Previous trans-urethral resection of the prostate
  • Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
  • Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
  • Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
  • History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Show all 9Show fewer
  • Hypersensitivity towards any component of the investigational product
  • Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
  • Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares-Madrid, 28805

  • Fundacion Hospital Alcorcón

    Alcorcón, 28922

  • Fundación Puigvert

    Barcelona, 08025

  • Hospital de Basurto

    Bilbao (Bizkaia), 48013

  • Hospital universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico Universitario S. Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Manacor

    Manacor, 07500

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Hospital Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Virgen Macarena

    Seville, 41014

  • Hospital Xeral de Vigo

    Vigo, 36204

Other trials in Spain

Germany10 sites

  • Facharztpraxis für Urologie

    Bamberg, 96047

  • Gemeinschaftspraxis

    Borken, 46325

  • Gemeinschaftspraxis

    Cologne, 50667

  • Universitätsklinikum Dresden

    Dresden, 01307

  • Euromed Clinic

    Fürth, 90763

  • Urologische Gemeinschaftspraxis

    Hamburg, 22399

  • VITURO Gesellschaft für Klinische Studien

    Leipzig, 04109

  • Klinikum Offenbach GmbH

    Offenbach, 63069

  • Urologische Klinik Planegg

    Planegg, 82152

  • Wuppertaler Gemeinschaftspraxis

    Wuppertal, 42103

Other trials in Germany

United Kingdom10 sites

  • United Bristol Healthcare NHSTrust Bristol Royal Infirmary

    Bristol, BS2 8HW

  • Falkirk and District Royal Infirmary

    Falkirk, FK1 5QE

  • Southern General Hospital

    Glasgow, G51 4TF

  • Castle Hill Hospital

    Hull, HU16 5JQ

  • Whipps Cross University Hospital

    London, E11 1NR

  • The Royal Free Hospital

    London, NW3 2QG

  • King's College Hospital

    London, SE5 9RS

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Hallamshire Hospital, Sheffield South

    Sheffield, S10 2JF

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

Other trials in United Kingdom

About this study

Official title: A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Conditions
Prostate Cancer
Being tested
Degarelix, Goserelin, Bicalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DegarelixDrug

    Also called FE200486

    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.

  • GoserelinDrug

    Also called Zoladex

    Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

  • BicalutamideDrug

    Also called Casodex

    On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.

Study groups in NCT00831233
Study groupRoleWhat they receive
Degarelix 240 mg/80 mgExperimentalDegarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
Receives: Drug: Degarelix
Goserelin (3.6 mg) + bicalutamide (50 mg)Active comparatorGoserelin (3.6 mg) + bicalutamide (50 mg)
Receives: Drug: Goserelin; Drug: Bicalutamide

What is being measured

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

  1. Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12

    The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

    Measured: After treatment of 12 weeks compared to Baseline

Secondary outcomes (9)

  1. Change From Baseline in Total IPSS at Weeks 4 and 8

    The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

    Measured: After treatment of 4 and 8 weeks compared to Baseline

  2. Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit

    Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)

    Measured: After treatment of 4, 8 and 12 weeks compared to Baseline

  3. Change From Baseline in Residual Volume (Vresidual) at Each Visit

    Uroflowmetry was used to quantify the residual volume (Vresidual; mL)

    Measured: After treatment of 4, 8 and 12 weeks compared to Baseline

  4. Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12

    TRUS is a method of measuring the size of the prostate.

    Measured: After 12 weeks treatment compared to Baseline

  5. Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit

    Measured: After treatment of 4, 8 and 12 weeks compared to Baseline

  6. Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit

    Measured: After treatment of 4, 8 and 12 weeks compared to Baseline

  7. Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit

    The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.

    Measured: After treatment of 4, 8 and 12 weeks compared to Baseline

  8. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

    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.

    Measured: Baseline to 12 weeks of treatment

  9. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

    The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.

    Measured: Baseline to 12 weeks of treatment

Timeline

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

  1. First posted28 Jan 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2010
  4. Study completionJul 2010

Why it stopped: Poor recruitment due to rare targeted population

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00831233
Sponsor's protocol ID
FE200486 CS28
Other IDs
2008-004338-26, 2008
Status last verified
Oct 2013
First submitted
27 Jan 2009
Last updated
11 Nov 2013
Data monitoring committee
No

Publications

  • Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15.

    PubMed 23258223

  • Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

    PubMed 34350976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Degarelix, Goserelin and Bicalutamide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 33 sites in 3 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Spain, Germany, United Kingdom. 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 26 Aug 2011). 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?

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 (time frame: After treatment of 12 weeks compared to Baseline). 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 NCT00831233, 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 11 Nov 2013.

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