Prostate CancerPhase 3NCT01220869

A Study of Degarelix in Taiwanese Patients With Prostate Cancer

A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 10 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer. Read more about this study

Who is it for?: Ages 20 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Degarelix
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 10 sitesTaiwan
Study dates: Dec 2010to Oct 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Taiwan10 sites

Changhua Christian Hospital
Changhua
Chang Gung Medical Foundation, Chiayi Branch
Chiayi City
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Chi-Mei Foundation Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkuo
Taoyuan

Other trials in Taiwan

About this study

Official title: An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.

Conditions: Prostate Cancer
Being tested: Degarelix
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DegarelixDrug
Also called degarelix acetate, Firmagon, FE200486
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).

Study groups in NCT01220869
Study group	Role	What they receive
Degarelix	Experimental	Not described Receives: Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From Day 28 to Day 168

Secondary outcomes (3)

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
Measured: Day 3
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
Measured: From Day 0 to Day 28
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.
Measured: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Oct 2012

First posted14 Oct 2010 (estimated)
Study startDec 2010
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01220869
Sponsor's protocol ID: FE200486 CS43
Status last verified: Dec 2013
First submitted: 13 Oct 2010
Last updated: 13 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
ClinicalTrials.gov ID: NCT01220869
Acronym / sponsor ID: FE200486 CS43
Conditions: Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 14 Oct 2010 (estimated)
Results: Posted 6 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Degarelix	Experimental	Drug: Degarelix

Who may qualify

Ages: 20 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DegarelixAlso: degarelix acetate, Firmagon, FE200486Degarelix 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).	Drug	Degarelix

Primary outcome

Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
Time frame: 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.

3 secondary outcomes

Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
Time frame: Day 3
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28
Time frame: From Day 0 to Day 28
Cumulative Probability of no PSA Failure
Time frame: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168

Results and safety

Results posted to the registry on 6 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Degarelix	110	104

Primary outcome: Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168

Time frame: From Day 28 to Day 168. Mean (95% Confidence Interval). Unit: Percentage of participants

Measure	Degarelix n = 101
Value	97.2 (91.6 to 99.1)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Degarelix	9 of 110 (8.2%)	69 of 110 (62.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingObservational study
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Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Support study director

Ferring Pharmaceuticals

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 10 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 (time frame: From Day 28 to Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.