Primary outcomeNumber· From Day 28 to Day 364
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
| Group | Value (percentage of participants) |
|---|---|
| Degarelix 240 mg/480 mg | 90.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Trial of Degarelix in Patients With Prostate Cancer
NCTNCT00946920 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS35Other id2008-005276-27Other id2008
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 859 participants (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Design
- Randomized · Open label (no masking)
- Countries
14 countries
United States, Belgium, Canada, Czechia, Finland, Germany, Hungary, Mexico, Netherlands, Poland, Romania, Russia, Ukraine, United Kingdom
- Start
- Jun 2009
- Primary completion
- Mar 2011
- Completion
- Mar 2011
- First posted
- 27 Jul 2009 (estimated)
- Last update posted
- 2 Jun 2014 (estimated)
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2009201020112012
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
Interventions
- DegarelixDrug
- Goserelin acetateDrug
Arms2
Experimental
Degarelix 240 mg/480 mg
Active comparator
Goserelin acetate
Primary outcomes2
Outcomes the sponsor listed as primary.
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
Time frame · From Day 28 to Day 364
Registry description
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
Time frame · Day 3 to Day 364
Registry description
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.
Secondary outcomes(4)
Serum Levels of Testosterone Over Time
Time frame · Baseline and after 1, 2, 3, 6 and 13 months
Registry description
Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Time frame · Baseline and after 1, 2, 3, 6 and 13 months
Registry description
Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
Time frame · At baseline, 10 months and 13 months
Registry description
The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
Time frame · At baseline, 1 month, 4 months, 7 months and 13 months
Registry description
IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Day 3 to Day 364
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
| Group | Value (percentage of participants) |
|---|---|
| Degarelix 240 mg/480 mg | 85.0 |
| Goserelin Acetate | 5.3 |
Secondary and other outcome results(4)
Secondary outcomeMedian· Baseline and after 1, 2, 3, 6 and 13 months
Serum Levels of Testosterone Over Time
| Group | Value (ng/mL) |
|---|---|
| Degarelix 240 mg/480 mg | 0.10 |
| Goserelin Acetate | 0.16 |
Secondary outcomeMean· Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
| Group | Value (percent change) | Spread |
|---|---|---|
| Degarelix 240 mg/480 mg | -77 | 23.7 |
| Goserelin Acetate | -57 | 45.7 |
Secondary outcomeMean· At baseline, 10 months and 13 months
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Degarelix 240 mg/480 mg | 0.52 | 11.1 |
| Goserelin Acetate | 0.27 | 10.6 |
Secondary outcomeMean· At baseline, 1 month, 4 months, 7 months and 13 months
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Degarelix 240 mg/480 mg | -1.06 | 6.27 |
| Goserelin Acetate | -0.21 | 6.22 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Degarelix 240 mg/480 mgDegarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations). | – | 58 / 565 | 336 / 565 |
| Goserelin AcetateGoserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants). | – | 33 / 283 | 125 / 283 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 18 years or older.
* Has a histological confirmed prostate cancer Gleason graded).
* Has a screening testosterone above 2.2 ng/mL.
* Rising prostate-specific antigen (PSA).
* Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
* Has a life expectancy of at least one year.
Exclusion Criteria:
* Current or previous hormone therapy.
* Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
* Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Has a heart insufficiency.
* Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
* Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
* Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
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