Symptomatic Study Investigating Degarelix in Patients Suffering From Prosta... | Stopped
Symptomatic Study Investigating Deg... | Stopped
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

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Medical Conditions
  • Prostate Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Stopped
Trial source and source ID number
NCT00831233

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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. 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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Degarelix, Drug : Goserelin, Drug : Bicalutamide

Study Arm Groups : Degarelix 240 mg/80 mg, Goserelin (3.6 mg) + bicalutamide (50 mg), Goserelin (3.6 mg) + bicalutamide (50 mg)

Intervention Type
See Interventions above
Primary Outcome Measures
    Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12; After treatment of 12 weeks compared to Baseline
Secondary Outcome Measures
    Change From Baseline in Total IPSS at Weeks 4 and 8; After treatment of 4 and 8 weeks compared to Baseline; Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Change From Baseline in Residual Volume (Vresidual) at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12; After 12 weeks treatment compared to Baseline; Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit; After treatment of 4, 8 and 12 weeks compared to Baseline; Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight; Baseline to 12 weeks of treatment; Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables; Baseline to 12 weeks of treatment
Publication(s)
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.; 23258223
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - 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.

    Exclusion Criteria:

    - 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.

    - 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
NW3 2QG
GSK Investigational Site
Sheffield
S10 2JF
Southern General Hospital
Glasgow
Scotland
G51 4TF
King's College Hospital
London
SE5 9RS
Plymouth
PL6 8DH
Sunderland Royal Hospital
Sunderland
Tyne and Wear
SR4 7TP
London
E11 1NR
Bristol
BS2 8HW
Castle Hill Hospital
Cottingham
England
HU16 5JQ
Falkirk and District Royal Infirmary
Falkirk
Scotland
FK1 5QE
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Germany, Spain, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
FE200486 CS28
Sponsor(s)
Ferring Pharmaceuticals
Key Dates

Recruitment Start Date

Apr 2009

Recruitment End Date

Jun 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Jan 2009

Date updated in source

18 Oct 2013