Trial Outcomes & Findings for A Study of Degarelix in Taiwanese Patients With Prostate Cancer (NCT NCT01220869)

NCT ID: NCT01220869

Last Updated: 2025-04-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

110 participants

Primary outcome timeframe

From Day 28 to Day 168

Results posted on

2025-04-13

Participant Flow

The participants were recruited among the patients attending the clinics included in the trial

125 participants were screened and 110 participants were enrolled and exposed to degarelix.

Participant milestones

Participant milestones
Measure	Degarelix 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).
Overall Study STARTED	110
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Degarelix n=110 Participants Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	91 Participants n=5 Participants
Age, Continuous	73.8 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants
Region of Enrollment Taiwan	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Degarelix n=101 Participants 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).
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168	97.2 Percentage of participants Interval 91.6 to 99.1

SECONDARY outcome

Timeframe: 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

Proportion of participants with testosterone at castrate level (\<= 0.5 ng/mL) at Day 3

Outcome measures

Outcome measures
Measure	Degarelix n=108 Participants 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).
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3	93.5 Percentage of participants Interval 87.1 to 97.4

SECONDARY outcome

Timeframe: 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

Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28

Outcome measures

Outcome measures
Measure	Degarelix n=106 Participants 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).
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28	-92.4 Percentage change of PSA Interval -96.0 to -83.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Degarelix n=110 Participants 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).
Cumulative Probability of no PSA Failure Day 0	100 Percentage of participants Interval 96.6 to 100.0
Cumulative Probability of no PSA Failure Day 0 to <= Day 7	100 Percentage of participants Interval 96.6 to 100.0
Cumulative Probability of no PSA Failure Day 0 to <= Day 28	100 Percentage of participants Interval 96.6 to 100.0
Cumulative Probability of no PSA Failure Day 0 to <= Day 112	99.1 Percentage of participants Interval 93.5 to 99.9
Cumulative Probability of no PSA Failure Day 0 to <= Day 140	98.1 Percentage of participants Interval 92.6 to 99.5
Cumulative Probability of no PSA Failure Day 0 to <= Day 168	96.2 Percentage of participants Interval 90.1 to 98.5

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 28 to Day 168

Population: The PP analysis set included all participants from the FAS analysis set without major protocol violations.

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.

Outcome measures

Outcome measures
Measure	Degarelix n=101 Participants 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).
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 Interval 91.6 to 99.1

Adverse Events

Degarelix

Serious events: 9 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Degarelix n=110 participants at risk 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).
Blood and lymphatic system disorders Leukaemoid reaction	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Cardiac disorders Acute myocardial infarction	1.8% 2/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Cardiac disorders Atrioventricular block complete	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Eye disorders Glaucoma	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
General disorders Oedema peripheral	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Infections and infestations Staphylococcal bacteraemia	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Investigations Carcinoembryonic antigen increased	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Musculoskeletal and connective tissue disorders Chest wall mass	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Nervous system disorders Headache	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Bladder obstruction	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Calculus bladder	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Nephrotic syndrome	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Renal failure acute	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Renal tubular necrosis	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Vascular disorders Hypertension	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Infections and infestations Pneumonia	0.91% 1/110 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.

Other adverse events

Other adverse events
Measure	Degarelix n=110 participants at risk 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).
Blood and lymphatic system disorders Anaemia	6.4% 7/110 • Number of events 8 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Gastrointestinal disorders Constipation	7.3% 8/110 • Number of events 8 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
General disorders Injection site erythema	28.2% 31/110 • Number of events 92 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
General disorders Injection site pain	24.5% 27/110 • Number of events 75 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
General disorders Injection site induration	16.4% 18/110 • Number of events 78 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
General disorders Injection site swelling	15.5% 17/110 • Number of events 20 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Hepatobiliary disorders Hepatic function abnormal	9.1% 10/110 • Number of events 11 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Infections and infestations Urinary tract infection	5.5% 6/110 • Number of events 7 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Nervous system disorders Dizziness	6.4% 7/110 • Number of events 7 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Renal and urinary disorders Dysuria	9.1% 10/110 • Number of events 10 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Vascular disorders Hot flush	10.0% 11/110 • Number of events 11 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.4% 7/110 • Number of events 7 • Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days. Adverse events were evaluated at each visit.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Publication restrictions are in place

Restriction type: OTHER