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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Prostate Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT00831233
Primary Trial ID Number
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. Epub 2012 Dec 15.; 23258223
Result Reports
This is available on the Clinicaltrials.gov website
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
Trial Location(s)
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
Derriford Hospital
Plymouth
England
PL6 8DH
Sunderland Royal Hospital
Sunderland
England
SR4 7TP
London
NW3 2QG
King's College Hospital
London
England
SE5 9RS
Hull
East Yorks
HU16 5JQ
University Hospitals Bristol NHS Trust
Bristol
Avon
BS2 8HW
The Southern Hospital, Neurology Department
Glasgow
Scotland
G51 4TF
Research Site
London
E11 1NR
Falkirk & 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
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 Assigned

27 Jan 2009

Last Updated

18 Oct 2013