A Phase 3 interventional study of Degarelix and Goserelin acetate in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Completed at 126 sites in 14 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by Ferring Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 859 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
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Exclusion Criteria:
Drug: Degarelix
Drug: Goserelin acetate
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).
Also known as: Firmagon, FE200486
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).
Also known as: Zoladex
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
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.
Time frame: From Day 28 to Day 364
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
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.
Time frame: Day 3 to Day 364
Serum Levels of Testosterone Over Time
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.
Time frame: Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
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.
Time frame: Baseline and after 1, 2, 3, 6 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
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.
Time frame: At baseline, 10 months and 13 months
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
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.
Time frame: At baseline, 1 month, 4 months, 7 months and 13 months
Subjects who met the eligibility criteria were randomized to degarelix or goserelin acetate treatment in a 2:1-ratio. 859 subjects were randomized but 11 subjects did not receive any treatment.
| Milestone | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Started | 565 | 283 |
| Full analysis set (fas) | 565 | 282 |
| Completed | 455 | 239 |
| Not completed | 110 | 44 |
| Withdrew: Withdrawal by subject | 28 | 15 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Physician decision | 5 | 2 |
| Withdrew: Adverse event | 41 | 14 |
| Withdrew: Protocol violation | 16 | 8 |
| Withdrew: Miscellaneous reasons | 18 | 3 |
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.
| percentage of participants | Degarelix 240 mg/480 mg |
|---|---|
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix | 90.0 (87.0 to 92.3) |
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.
| percentage of participants | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin | 85.0 (81.6 to 87.8) | 5.3 (3.1 to 8.4) |
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.
| ng/mL | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Month 1 | 0.10 (0.015 to 3.85) | 0.16 (0.04 to 1.77) |
| Month 2 | 0.09 (0.015 to 0.41) | 0.10 (0.015 to 0.5) |
| Month 3 | 0.09 (0.015 to 3.24) | 0.09 (0.015 to 5.4) |
| Month 6 | 0.09 (0.015 to 1.57) | 0.09 (0.015 to 0.32) |
| Month 13 | 0.11 (0.015 to 4.19) | 0.09 (0.015 to 0.95) |
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.
| percent change | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Month 1 | -77 ± 23.7 | -57 ± 45.7 |
| Month 2 | -89 ± 12.6 | -86 ± 18.1 |
| Month 3 | -90 ± 15.4 | -86 ± 58.6 |
| Month 6 | -90 ± 30.5 | -91 ± 18.2 |
| Month 13 | -82 ± 104 | -77 ± 146 |
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.
| units on a scale | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Month 10 | 0.52 ± 11.1 | 0.27 ± 10.6 |
| Month 13 | 0.18 ± 10.9 | -0.87 ± 9.76 |
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.
| units on a scale | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Month 1 | -1.06 ± 6.27 | -0.21 ± 6.22 |
| Month 4 | -2.31 ± 6.65 | -1.74 ± 6.16 |
| Month 7 | -2.47 ± 6.94 | -2.45 ± 6.80 |
| Month 13 | -2.04 ± 7.28 | -1.52 ± 6.25 |
Collected over Adverse events were recorded from signed informed consent until the end-of-trial visit, Day 364 (Month 13).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Degarelix 240 mg/480 mg | — | 58/565 (10.3%) | 336/565 (59.5%) |
| Goserelin Acetate | — | 33/283 (11.7%) | 125/283 (44.2%) |
| Event | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/565 | 3/283 |
| AnaemiaBlood and lymphatic system disorders | 2/565 | 2/283 |
| Supraventricular tachycardiaCardiac disorders | 0/565 | 2/283 |
| Lobar pneumoniaInfections and infestations | 1/565 | 2/283 |
| PneumoniaInfections and infestations | 0/565 | 2/283 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/565 | 2/283 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/565 | 2/283 |
| Ischaemic strokeNervous system disorders | 3/565 | 1/283 |
| SyncopeNervous system disorders | 3/565 | 0/283 |
| Angina pectorisCardiac disorders | 2/565 | 0/283 |
| Event | Degarelix 240 mg/480 mg | Goserelin Acetate |
|---|---|---|
| Injection site painGeneral disorders | 173/565 | 4/283 |
| Hot flushVascular disorders | 160/565 | 76/283 |
| Injection site erythemaGeneral disorders | 122/565 | 0/283 |
| Injection site noduleGeneral disorders | 51/565 | 0/283 |
| Weight increasedInvestigations | 26/565 | 24/283 |
| Back painMusculoskeletal and connective tissue disorders | 19/565 | 21/283 |
| Urinary tract infectionInfections and infestations | 24/565 | 18/283 |
| HypertensionVascular disorders | 22/565 | 18/283 |
| Injection site swellingGeneral disorders | 34/565 | 0/283 |
| PyrexiaGeneral disorders | 31/565 | 7/283 |
FAS
| Age, Continuous(years) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| Mean | 71.9 ± 8.3 | 71.1 ± 7.9 | 71.6 ± 8.2 |
| Sex: Female, Male(Participants) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 565 | 282 | 847 |
| Race (NIH/OMB)(Participants) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 45 | 25 | 70 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 41 | 16 | 57 |
| White | 475 | 239 | 714 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Median Baseline Serum Testosterone Levels (ng/mL)(ng/mL) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| Median | 4.52 (0.56 to 14.5) | 4.62 (0.07 to 13.2) | 4.54 (0.07 to 14.5) |
| Median Baseline Serum Prostate-specific Antigen Levels (ng/mL)(ng/mL) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| Median | 19.0 (0.26 to 8762) | 19.1 (0.01 to 12961) | 19.0 (0.01 to 12961) |
| Baseline Short Form-36 (SF-36) Total Scores(units on a scale) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| Mean | 49.7 ± 11.5 | 50.2 ± 11.4 | 49.9 ± 11.4 |
| Baseline Total International Prostate Symptom Scores (IPSS)(units on a scale) | Degarelix 240 mg/480 mg | Goserelin Acetate | Total |
|---|---|---|---|
| Mean | 11.8 ± 7.93 | 11.6 ± 8.02 | 11.7 ± 7.96 |
Showing the first 100 of 126 sites across 14 countries.
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Ferring Pharmaceuticals