Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00831233
• Other study ID #: FE200486 CS28
• Secondary ID: 2008-004338-26
• Status: Terminated
• Phase: Phase 3
• First received: January 27, 2009
• Last updated: October 18, 2013
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
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.
• Goserelin
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.
• Bicalutamide
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.

Locations

Country	Name	City	State
Germany	Facharztpraxis für Urologie	Bamberg
Germany	Gemeinschaftspraxis	Borken
Germany	Universitätsklinikum Dresden	Dresden
Germany	Euromed Clinic	Fürth
Germany	Urologische Gemeinschaftspraxis	Hamburg
Germany	Gemeinschaftspraxis	Köln
Germany	VITURO Gesellschaft für Klinische Studien	Leipzig
Germany	Klinikum Offenbach GmbH	Offenbach
Germany	Urologische Klinik Planegg	Planegg
Germany	Wuppertaler Gemeinschaftspraxis	Wuppertal
Spain	Hospital Universitario Principe de Asturias	Alcalá de Henares-Madrid
Spain	Fundacion Hospital Alcorcón	Alcorcon
Spain	Fundación Puigvert	Barcelona
Spain	Hospital de Basurto	Bilbao (Bizkaia)
Spain	Complejo Hospitalario Universitario A Coruña	Coruña
Spain	Hospital Clinico Universitario S. Carlos	Madrid
Spain	Hospital universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda, Madrid
Spain	Hospital Manacor	Manacor
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Santiago de Compostela	Santiago de Compostela
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Xeral de Vigo	Vigo
United Kingdom	United Bristol Healthcare NHSTrust Bristol Royal Infirmary	Bristol
United Kingdom	Falkirk and District Royal Infirmary	Falkirk
United Kingdom	Southern General Hospital	Glasgow
United Kingdom	Castle Hill Hospital	Hull
United Kingdom	King's College Hospital	London
United Kingdom	The Royal Free Hospital	London
United Kingdom	Whipps Cross University Hospital	London
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Hallamshire Hospital, Sheffield South	Sheffield
United Kingdom	Sunderland Royal Hospital	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

References & Publications (1)

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 III — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After treatment of 12 weeks compared to Baseline	No
Secondary	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.	After treatment of 4 and 8 weeks compared to Baseline	No
Secondary	Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit	Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)	After treatment of 4, 8 and 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Residual Volume (Vresidual) at Each Visit	Uroflowmetry was used to quantify the residual volume (Vresidual; mL)	After treatment of 4, 8 and 12 weeks compared to Baseline	No
Secondary	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.	After 12 weeks treatment compared to Baseline	No
Secondary	Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit		After treatment of 4, 8 and 12 weeks compared to Baseline	No
Secondary	Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit		After treatment of 4, 8 and 12 weeks compared to Baseline	No
Secondary	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.	After treatment of 4, 8 and 12 weeks compared to Baseline	No
Secondary	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.	Baseline to 12 weeks of treatment	No
Secondary	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.	Baseline to 12 weeks of treatment	No