Prostate CancerPhase 3NCT01215513

Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 11 sites in South Korea.

Completed

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

Official record

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Trial summary

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Degarelix
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 11 sitesSouth Korea
Study dates: Sep 2010to Apr 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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
Has completed the 7-month main trial, FE200486 CS42

Who cannot join

Has been withdrawn/discontinued from the FE200486 CS42 trial
A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

South Korea11 sites

Kyoungbuk National University Hospital
Daegu, Daegu
Pusan National University Yangsan Hospital
Mulgeum-eup, Gyungnam
Hallym University Sacred Heart Hospital
Pyungchon, Gyunggi-do
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Korea University Hospital
Seoul, Anam-dong, Seongbuk-gu
Seoul St. Mary's Hospital
Seoul, Banpo-dong, Seocho-gu
Yonsei University Health System Gangnam Sevrance
Seoul, Eonguro, Gangnam-gu
Samsung Medical Center
Seoul, Ilwon-dong, Kangnam-gu
Asan Medical Center
Seoul, Pungnap-2-dong, Songpa-gu
Yonsei University Health System (Sevrance Hospital)
Seoul, Seongsanno, Seodaemun-gu
Seoul National University Hospital
Seoul, Yeongeon-dong, Chongno-gu

Other trials in South Korea

About this study

Official title: An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean 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

Study groups in NCT01215513
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.

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.
ULN=upper limit of normal
Measured: From baseline (day 0) to end of treatment (up to day 364)
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Measured: From baseline (day 0) to end of treatment (up to day 364)
Number of Participants With Markedly Abnormal Values in ECG Variables
This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Measured: From baseline (day 0) to end of treatment (up to day 364)

Secondary outcomes (1)

Serum Levels of Prostate Specific Antigen (PSA) Over Time
PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).
Measured: Day 0, day 196, day 280, and day 364

Timeline

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

Sep 2010Apr 2012

First posted6 Oct 2010 (estimated)
Study startSep 2010
Primary completionApr 2012
Study completionApr 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: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215513
Sponsor's protocol ID: FE200486 CS42A
Status last verified: Apr 2013
First submitted: 5 Oct 2010
Last updated: 22 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy
ClinicalTrials.gov ID: NCT01215513
Acronym / sponsor ID: FE200486 CS42A
Conditions: Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Ferring Pharmaceuticals Korea, Ltd.
Study start: Sep 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 22 May 2013

Clinical summary

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

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean 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: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
Has completed the 7-month main trial, FE200486 CS42

Key exclusion criteria (2 listed)

Has been withdrawn/discontinued from the FE200486 CS42 trial
A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

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
Degarelix	Drug	Degarelix

Primary outcome

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame: From baseline (day 0) to end of treatment (up to day 364)
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame: From baseline (day 0) to end of treatment (up to day 364)
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Number of Participants With Markedly Abnormal Values in ECG Variables
Time frame: From baseline (day 0) to end of treatment (up to day 364)
This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

1 secondary outcome

Serum Levels of Prostate Specific Antigen (PSA) Over Time
Time frame: Day 0, day 196, day 280, and day 364

Results and safety

Results posted to the registry on 22 May 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	157	112

Primary outcome: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

Time frame: From baseline (day 0) to end of treatment (up to day 364). Number. Unit: Participants

Measure	Degarelix n = 156
S-Alanine aminotransferase (IU/L) >3xULN	1
S-Cholesterol (mmol/L) >=8.0	1
S-Potassium (mmol/L) >=5.8	10
S-Sodium (mmol/L) <=130	2
S-Total bilirubin (micromol/L) >1.5xULN	1
S-Urea nitrogen (mmol/L) >=10.7	10
B-Basophils (%) >=5	1
B-Eosinophils (%) >=10	7

Population analysed: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).

Primary outcome: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Time frame: From baseline (day 0) to end of treatment (up to day 364). Number. Unit: Participants

Measure	Degarelix n = 156
Diastolic blood pressure <=50 and decrease >=15	13
Diastolic blood pressure >=105 and increase >=15	0
Systolic blood pressure <=90 and decrease >=20	20
Systolic blood pressure >=180 and increase >=20	1
Pulse rate <=50 and decrease >=15	10
Pulse rate >=120 and increase >=15	0
Body weight decrease of >=7% from baseline	4
Body weight increase of >=7% from baseline	12

Population analysed: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).

Primary outcome: Number of Participants With Markedly Abnormal Values in ECG Variables

Time frame: From baseline (day 0) to end of treatment (up to day 364). Number. Unit: Participants

Measure	Degarelix n = 156
PR interval (msec) <=120	1
PR interval (msec) >=220	3
QRS interval (msec) >=120	3
QT interval (msec) >=450	27
QT interval (msec) >=480	6
QT interval (msec) >=500	2
QT interval increase of >=30 from baseline	69
QT interval increase of >=60 from baseline	20

Population analysed: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From baseline (day 0) to end of treatment (up to day 364). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Degarelix	25 of 156 (16%)	88 of 156 (56.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
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
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Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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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

11 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 11 sites in South Korea.

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 2 inclusion and 2 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 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. 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 22 May 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?

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables (time frame: From baseline (day 0) to end of treatment (up to day 364)). The study lists 3 primary outcomes in all. 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 NCT01215513.

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 22 May 2013.