Prostate Cancer
Conditions
Brief summary
A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
Interventions
DRUGDegarelix
Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 20 years or older * Has a histological confirmed prostate cancer * Has a screening serum testosterone above 1.5 ng/mL * Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2 * Has a screening PSA value of ≥2 ng/mL * Has a life expectancy of at least 168 days
Exclusion criteria
* Current or previous hormone therapy * Is currently treated with 5-α-reductase inhibitor * Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema * Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy * Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. * Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator * Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 | From Day 28 to Day 168 | Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3 | Day 3 | Proportion of participants with testosterone at castrate level (\<= 0.5 ng/mL) at Day 3 |
| Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28 | From Day 0 to Day 28 | Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28 |
| Cumulative Probability of no PSA Failure | Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168 | The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis | From Day 28 to Day 168 | Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis. |
Countries
Taiwan
Participant flow
Recruitment details
The participants were recruited among the patients attending the clinics included in the trial
Pre-assignment details
125 participants were screened and 110 participants were enrolled and exposed to degarelix.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose) | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Degarelix |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 91 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 73.8 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment Taiwan | 110 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 69 / 110 |
| serious Total, serious adverse events | 9 / 110 |
Outcome results
Primary
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.
Time frame: From Day 28 to Day 168
Population: The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix | Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 | 97.2 Percentage of participants |
Secondary
Cumulative Probability of no PSA Failure
The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.
Time frame: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168
Population: The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Degarelix | Cumulative Probability of no PSA Failure | Day 0 | 100 Percentage of participants |
| Degarelix | Cumulative Probability of no PSA Failure | Day 0 to <= Day 7 | 100 Percentage of participants |
| Degarelix | Cumulative Probability of no PSA Failure | Day 0 to <= Day 28 | 100 Percentage of participants |
| Degarelix | Cumulative Probability of no PSA Failure | Day 0 to <= Day 112 | 99.1 Percentage of participants |
| Degarelix | Cumulative Probability of no PSA Failure | Day 0 to <= Day 140 | 98.1 Percentage of participants |
| Degarelix | Cumulative Probability of no PSA Failure | Day 0 to <= Day 168 | 96.2 Percentage of participants |
Secondary
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28
Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28
Time frame: From Day 0 to Day 28
Population: The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix | Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28 | -92.4 Percentage change of PSA |
Secondary
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
Proportion of participants with testosterone at castrate level (\<= 0.5 ng/mL) at Day 3
Time frame: Day 3
Population: The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix | Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3 | 93.5 Percentage of participants |
Other Pre-specified
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis
Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.
Time frame: From Day 28 to Day 168
Population: The PP analysis set included all participants from the FAS analysis set without major protocol violations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Degarelix | Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis | 97.2 Percentage of participants |