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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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 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.
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.
Facharztpraxis für Urologie
Bamberg, Germany
Gemeinschaftspraxis
Borken, Germany
Gemeinschaftspraxis
Cologne, Germany
Universitätsklinikum Dresden
Dresden, Germany
Euromed Clinic
Fürth, Germany
Urologische Gemeinschaftspraxis
Hamburg, Germany
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.
Time frame: After treatment of 12 weeks compared to Baseline
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.
Time frame: After treatment of 4 and 8 weeks compared to Baseline
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit
Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Change From Baseline in Residual Volume (Vresidual) at Each Visit
Uroflowmetry was used to quantify the residual volume (Vresidual; mL)
Time frame: 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
TRUS is a method of measuring the size of the prostate.
Time frame: After 12 weeks treatment compared to Baseline
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit
Time frame: 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
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.
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
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.
Time frame: Baseline to 12 weeks of treatment
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.
Time frame: Baseline to 12 weeks of treatment
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VITURO Gesellschaft für Klinische Studien
Leipzig, Germany
Klinikum Offenbach GmbH
Offenbach, Germany
Urologische Klinik Planegg
Planegg, Germany
Wuppertaler Gemeinschaftspraxis
Wuppertal, Germany
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