Prostate Cancer
Conditions
Brief summary
The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.
Detailed description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Interventions
DRUGDegarelix
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained before any trial related procedures * Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy * ECOG score to be equal to or above 2 * Testosterone level within age-specific normal range * PSA value equal to or above 2 ng/ml * Life expectancy of at least 6 months
Exclusion criteria
* Previous or current hormonal treatment of prostate cancer * Recent or current treatment with any drugs modifying the testosterone level * Candidate for curative treatment such as prostatectomy or radiotherapy * History of severe asthma, anaphylactic reactions or Quincke's Oedema * Hypersensitivity towards any component of FE200486 * Cancer disease within the last ten years except for prostate cancer and some skin cancers * Signs of liver impairment shown as elevated serum ALT or serum bilirubin * Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results * Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator * Mental incapacity or language barrier * Having received an investigational product within the last 12 weeks preceding the trial * Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Dosing Until Testosterone Levels >0.5 ng/mL | 3 months | Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value \>0.5 ng/mL at Day 28 onwards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 3 months | The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days. |
| Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 3 months | Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. |
| Time to 50% Reduction in Prostate-specific Antigen Levels | 3 months | The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached. |
| Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | Two - six months | The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days. |
| Evaluation of Liver Function Tests | 3 months | The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN. |
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | 3 months | Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline. |
| Time to 90% Reduction in Prostate-specific Antigen Levels | 3 months | The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached. |
Countries
Denmark, Finland, Hungary, Norway, Romania, Russia, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 120mg (20mg/mL) Degarelix 120 mg (20 mg/mL) | 25 |
| Degarelix 120mg (40mg/mL) Degarelix 120 mg (40 mg/mL) | 12 |
| Degarelix 160mg (40mg/mL) Degarelix 160 mg (40 mg/mL) | 12 |
| Degarelix 200mg (40mg/mL) Degarelix 200 mg (40 mg/mL) | 24 |
| Degarelix 200mg (60mg/mL) Degarelix 200 mg (60 mg/mL) | 24 |
| Degarelix 240mg (40mg/mL) Degarelix 240 mg (40 mg/mL) | 24 |
| Degarelix 240mg (60mg/mL) Degarelix 240 mg (60 mg/mL) | 24 |
| Degarelix 320mg (60mg/mL) Degarelix 320 mg (60 mg/mL) | 27 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Bad prostate specific antigen response | 0 | 3 | 2 | 5 | 0 | 1 | 0 | 0 |
| Overall Study | Disease progression | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lack of trial drug at site | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Need of additional treatment | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Degarelix 120mg (40mg/mL) | Degarelix 160mg (40mg/mL) | Degarelix 200mg (40mg/mL) | Degarelix 200mg (60mg/mL) | Degarelix 120mg (20mg/mL) | Degarelix 240mg (40mg/mL) | Degarelix 240mg (60mg/mL) | Degarelix 320mg (60mg/mL) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 10 Participants | 22 Participants | 20 Participants | 18 Participants | 22 Participants | 18 Participants | 21 Participants | 143 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants | 4 Participants | 7 Participants | 2 Participants | 6 Participants | 6 Participants | 29 Participants |
| Age, Continuous | 73.8 years STANDARD_DEVIATION 3.97 | 70.1 years STANDARD_DEVIATION 8.08 | 74.3 years STANDARD_DEVIATION 6.48 | 71.5 years STANDARD_DEVIATION 8.27 | 70.0 years STANDARD_DEVIATION 10.3 | 73.1 years STANDARD_DEVIATION 5.96 | 71.7 years STANDARD_DEVIATION 9.54 | 71.1 years STANDARD_DEVIATION 6.87 | 71.9 years STANDARD_DEVIATION 7.83 |
| Body mass index | 26.6 kilgram per square meter STANDARD_DEVIATION 4.58 | 26.3 kilgram per square meter STANDARD_DEVIATION 3.74 | 25.9 kilgram per square meter STANDARD_DEVIATION 2.99 | 24.5 kilgram per square meter STANDARD_DEVIATION 2.92 | 26.2 kilgram per square meter STANDARD_DEVIATION 2.97 | 26.9 kilgram per square meter STANDARD_DEVIATION 3.18 | 24.8 kilgram per square meter STANDARD_DEVIATION 2.72 | 27.1 kilgram per square meter STANDARD_DEVIATION 3.63 | 26.0 kilgram per square meter STANDARD_DEVIATION 3.32 |
| Curative intent No | 12 participants | 10 participants | 21 participants | 23 participants | 25 participants | 24 participants | 24 participants | 26 participants | 165 participants |
| Curative intent Yes | 0 participants | 2 participants | 3 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 7 participants |
| Gleason score 0-1 | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Gleason score 2-4 | 0 participants | 2 participants | 1 participants | 5 participants | 4 participants | 2 participants | 5 participants | 12 participants | 31 participants |
| Gleason score 5-6 | 7 participants | 5 participants | 6 participants | 3 participants | 4 participants | 6 participants | 6 participants | 6 participants | 43 participants |
| Gleason score 7-10 | 5 participants | 5 participants | 17 participants | 16 participants | 17 participants | 16 participants | 13 participants | 9 participants | 98 participants |
| Race/Ethnicity, Customized Caucasian | 12 participants | 12 participants | 24 participants | 24 participants | 25 participants | 24 participants | 24 participants | 27 participants | 172 participants |
| Serum prostate-specific antigen levels | 58.8 nanogram per milliliter | 109 nanogram per milliliter | 32.3 nanogram per milliliter | 46.9 nanogram per milliliter | 42.5 nanogram per milliliter | 31.0 nanogram per milliliter | 31.9 nanogram per milliliter | 23.8 nanogram per milliliter | 37.9 nanogram per milliliter |
| Serum testosterone levels | 3.10 nanogram per milliliter | 3.02 nanogram per milliliter | 4.64 nanogram per milliliter | 5.60 nanogram per milliliter | 4.30 nanogram per milliliter | 4.02 nanogram per milliliter | 4.46 nanogram per milliliter | 3.68 nanogram per milliliter | 4.16 nanogram per milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants | 24 Participants | 25 Participants | 24 Participants | 24 Participants | 27 Participants | 172 Participants |
| Stage of prostate cancer Localized | 1 participants | 3 participants | 3 participants | 1 participants | 10 participants | 6 participants | 8 participants | 14 participants | 46 participants |
| Stage of prostate cancer Locally advanced | 6 participants | 5 participants | 14 participants | 8 participants | 6 participants | 10 participants | 5 participants | 9 participants | 63 participants |
| Stage of prostate cancer Metastatic | 3 participants | 4 participants | 6 participants | 12 participants | 9 participants | 6 participants | 10 participants | 2 participants | 52 participants |
| Stage of prostate cancer Not classifiable | 2 participants | 0 participants | 1 participants | 3 participants | 0 participants | 2 participants | 1 participants | 2 participants | 11 participants |
| Time since prostate cancer diagnosis | 65.9 days STANDARD_DEVIATION 53.5 | 222 days STANDARD_DEVIATION 328 | 146 days STANDARD_DEVIATION 298 | 252 days STANDARD_DEVIATION 560 | 83.2 days STANDARD_DEVIATION 157 | 313 days STANDARD_DEVIATION 837 | 121 days STANDARD_DEVIATION 425 | 46.6 days STANDARD_DEVIATION 54.4 | 156 days STANDARD_DEVIATION 439 |
| Weight | 82.2 kilogram STANDARD_DEVIATION 12.1 | 80.7 kilogram STANDARD_DEVIATION 11.8 | 78.2 kilogram STANDARD_DEVIATION 13.7 | 74.2 kilogram STANDARD_DEVIATION 9.88 | 77.8 kilogram STANDARD_DEVIATION 12.4 | 81.5 kilogram STANDARD_DEVIATION 10.7 | 73.5 kilogram STANDARD_DEVIATION 9.55 | 81.7 kilogram STANDARD_DEVIATION 11.1 | 78.4 kilogram STANDARD_DEVIATION 11.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / — | 10 / — | 7 / — | 20 / — | 14 / — | 22 / — | 10 / — | 19 / — |
| serious Total, serious adverse events | 2 / — | 2 / — | 1 / — | 2 / — | 1 / — | 4 / — | 3 / — | 4 / — |
Outcome results
Primary
Time From Dosing Until Testosterone Levels >0.5 ng/mL
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value \>0.5 ng/mL at Day 28 onwards.
Time frame: 3 months
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 120mg (20mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 84 days |
| Degarelix 120mg (40mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 63 days |
| Degarelix 160mg (40mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 70 days |
| Degarelix 200mg (40mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 140 days |
| Degarelix 200mg (60mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 84 days |
| Degarelix 240mg (40mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 140 days |
| Degarelix 240mg (60mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 87.5 days |
| Degarelix 320mg (60mg/mL) | Time From Dosing Until Testosterone Levels >0.5 ng/mL | 133 days |
p-value: 0.0000586Log Rank
Secondary
Evaluation of Liver Function Tests
The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 120mg (20mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 2 participants |
| Degarelix 120mg (20mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 6 participants |
| Degarelix 120mg (20mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 9 participants |
| Degarelix 120mg (20mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 120mg (20mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 120mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 120mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 1 participants |
| Degarelix 120mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 120mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 2 participants |
| Degarelix 120mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 3 participants |
| Degarelix 160mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 3 participants |
| Degarelix 160mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 160mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 1 participants |
| Degarelix 160mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 160mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 200mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 200mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 7 participants |
| Degarelix 200mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 4 participants |
| Degarelix 200mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 200mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 200mg (60mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 200mg (60mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 200mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 200mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 7 participants |
| Degarelix 200mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 8 participants |
| Degarelix 240mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 1 participants |
| Degarelix 240mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 1 participants |
| Degarelix 240mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 4 participants |
| Degarelix 240mg (40mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 3 participants |
| Degarelix 240mg (40mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 240mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 5 participants |
| Degarelix 240mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 6 participants |
| Degarelix 240mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 0 participants |
| Degarelix 240mg (60mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 240mg (60mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 1 participants |
| Degarelix 320mg (60mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN, bilirubin >1.5x ULN | 0 participants |
| Degarelix 320mg (60mg/mL) | Evaluation of Liver Function Tests | ALAT >3x ULN | 0 participants |
| Degarelix 320mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal alanine aminotransferase (ALAT) | 6 participants |
| Degarelix 320mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal aspartate aminotransferase | 5 participants |
| Degarelix 320mg (60mg/mL) | Evaluation of Liver Function Tests | Abnormal bilirubin | 1 participants |
Secondary
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
Time frame: Two - six months
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 120mg (20mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 21 participants |
| Degarelix 120mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 8 participants |
| Degarelix 160mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 6 participants |
| Degarelix 200mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 24 participants |
| Degarelix 200mg (60mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 18 participants |
| Degarelix 240mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 22 participants |
| Degarelix 240mg (60mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 15 participants |
| Degarelix 320mg (60mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days | 24 participants |
p-value: 0.0014Kruskal-Wallis
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [66.1, 95.8]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [33.7, 86]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [22.9, 78]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [85.8, 100]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [52.6, 87.9]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [72.9, 99.4]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [40.3, 78.4]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.95% CI: [69.4, 96.3]
Secondary
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
Time frame: 3 months
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 120mg (20mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 11 participants |
| Degarelix 120mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 4 participants |
| Degarelix 160mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 3 participants |
| Degarelix 200mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 20 participants |
| Degarelix 200mg (60mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 11 participants |
| Degarelix 240mg (40mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 18 participants |
| Degarelix 240mg (60mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 12 participants |
| Degarelix 320mg (60mg/mL) | Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days | 19 participants |
p-value: 0.0031Kruskal-Wallis
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [25.6, 64]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [12.1, 64.3]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [8.3, 60.6]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [61.5, 93.4]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [28.3, 67.4]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [58.8, 92.8]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [29.1, 67.8]
Comparison: Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.95% CI: [49.4, 83.9]
Secondary
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
Time frame: 3 months
Population: ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 2 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 120mg (20mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 1 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 1 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 120mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 1 participants |
| Degarelix 160mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 2 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 2 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 3 participants |
| Degarelix 200mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 1 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 1 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 200mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 240mg (40mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 1 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 1 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 3 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Degarelix 240mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 320mg (60mg/mL) | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Body weight increase of >=7 percent | 1 participants |
Secondary
Time to 50% Reduction in Prostate-specific Antigen Levels
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Time frame: 3 months
Population: ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 120mg (20mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
| Degarelix 120mg (40mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 21 days |
| Degarelix 160mg (40mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
| Degarelix 200mg (40mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
| Degarelix 200mg (60mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
| Degarelix 240mg (40mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
| Degarelix 240mg (60mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
| Degarelix 320mg (60mg/mL) | Time to 50% Reduction in Prostate-specific Antigen Levels | 14 days |
p-value: 0.033Log Rank
Secondary
Time to 90% Reduction in Prostate-specific Antigen Levels
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Time frame: 3 months
Population: ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 120mg (20mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 31.5 days |
| Degarelix 120mg (40mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 35 days |
| Degarelix 160mg (40mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 42 days |
| Degarelix 200mg (40mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 35 days |
| Degarelix 200mg (60mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 28 days |
| Degarelix 240mg (40mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 42 days |
| Degarelix 240mg (60mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 35 days |
| Degarelix 320mg (60mg/mL) | Time to 90% Reduction in Prostate-specific Antigen Levels | 45.5 days |
p-value: 0.131Log Rank
Secondary
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.
Time frame: 3 months
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 120mg (20mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 1 days |
| Degarelix 120mg (40mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 1 days |
| Degarelix 160mg (40mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 1.5 days |
| Degarelix 200mg (40mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 1.5 days |
| Degarelix 200mg (60mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 2 days |
| Degarelix 240mg (40mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 1.5 days |
| Degarelix 240mg (60mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 2 days |
| Degarelix 320mg (60mg/mL) | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) | 1 days |
p-value: 0.0866Log Rank