Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, France, Germany, Greece, Netherlands, Spain, United Kingdom
1 trial · 1 completed · 1 with posted results
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT00833248Apr 2009 to Sept 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
Experimental
Degarelix 240 mg/80 mg
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.
Active comparator
Goserelin (3.6 mg) + bicalutamide (50 mg)
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Outcomes the sponsor listed as primary.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Time frame · After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
Time frame · After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
Time frame · After treatment of 4, 8, and 12 weeks compared to Baseline
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.
Change From Baseline in Serum Testosterone Levels During the Study
Time frame · After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time frame · After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Oestradiol Levels During the Study
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
Time frame · After treatment of 4, 8, and 12 weeks compared to Baseline
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').
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame · Baseline to 12 weeks of treatment
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.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame · Baseline to 12 weeks of treatment
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 one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (milliliter) | Spread |
|---|---|---|
| Degarelix 240 mg/80 mg | -36.0 | 14.5 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | -35.3 | 16.7 |
| Group | Value (milliliter) | Spread |
|---|---|---|
| Degarelix 240 mg/80 mg | -36.2 | 14.5 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | -35.4 | 16.9 |
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Degarelix 240 mg/80 mg | -0.21 | 5.05 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | 0.36 | 4.83 |
| Group | Value (nanograms per milliliter) |
|---|---|
| Degarelix 240 mg/80 mg | -3.8 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | -4.22 |
| Group | Value (nanograms per milliliter) |
|---|---|
| Degarelix 240 mg/80 mg | -6.3 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | -5.9 |
| Group | Value (nanogram per deciliter) |
|---|---|
| Degarelix 240 mg/80 mg | -1.55 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | -1.65 |
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Degarelix 240 mg/80 mg | -0.07 | 1.31 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | 0.16 | 0.92 |
| Group | Value (participants) |
|---|---|
| Degarelix 240 mg/80 mg | 0 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Degarelix 240 mg/80 mgThe 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. | – | 7 / 181 | 158 / 181 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg)On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. | – | 0 / 64 | 53 / 64 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2013
Mason et al. 2013Clinical oncology (Royal College of Radiologists (Great Britain))cited by 56
PMID 23257248DOI 10.1016/j.clon.2012.09.010PUB-23257248
References listed at the registry that are not in PepBank. They link to PubMed.
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