Prostate CancerPhase 3NCT01071915
Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
A Phase 3 study testing Degarelix 240/80 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 11 sites in South Korea.
Trial summary
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results. 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 240/80 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Mar 2010to Nov 2011
- 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.
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
- Is a male patient aged 18 years or older
- Has a screening serum testosterone level >1.5 ng/mL
- Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
- Has a screening PSA value of ≥2 ng/mL
- Has a life expectancy of at least 12 months
Who cannot join
- Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
- Is currently treated with a 5-α-reductase inhibitor
- Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
- Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
- Has hypersensitivity towards any component of the investigational medicinal product
- A marked baseline prolongation of QT/QTcF interval
Show all 15Show fewer
- A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
- Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
- Has a known or suspect hepatic, symptomatic biliary disease
- Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
- Has other clinically significant laboratory abnormalities
- Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
- Has a mental incapacity or language barriers precluding adequate understanding or co- operation
- 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
- Has previously participated in any degarelix trial
Trial locations and contacts
11 sites in 1 country.
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
Asan Medical Center
Seoul
Korea University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
Yonsei University Health System (Sevrance Hospital)
Seoul
Yonsei University Health System Gangnam Sevrance
Seoul
About this study
Official title: An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix 240/80 mg
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix 240/80 mgDrug
Also called FE200486, FIRMAGON
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 240/80 mg | Experimental | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168. Receives: Drug: Degarelix 240/80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
Measured: Day 28 to Day 196
Secondary outcomes (6)
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Measured: At day 3
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Measured: To Day 28
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Measured: Day 56 to Day 196
Cumulative Probability of no PSA Failure From Day 28 to Day 196
PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Measured: To Day 196
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 percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Measured: To Day 196
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 table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Measured: To Day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionNov 2011
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
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals Korea, Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071915
- Sponsor's protocol ID
- FE200486 CS42
- Status last verified
- Jan 2013
- First submitted
- 18 Feb 2010
- Last updated
- 12 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy
- ClinicalTrials.gov ID
- NCT01071915
- Acronym / sponsor ID
- FE200486 CS42
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals Korea, Ltd.
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 12 Feb 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 efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degarelix 240/80 mg | Experimental | Drug: Degarelix 240/80 mgThe degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has given written informed consent before any trial-related activity is performed.
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
- Is a male patient aged 18 years or older
- Has a screening serum testosterone level >1.5 ng/mL
- Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
Key exclusion criteria (15 listed)
- Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
- Is currently treated with a 5-α-reductase inhibitor
- Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
- Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
- Has hypersensitivity towards any component of the investigational medicinal product
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 240/80 mgAlso: FE200486, FIRMAGONThe degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168. | Drug | Degarelix 240/80 mg |
Primary outcome
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
Time frame: Day 28 to Day 196
6 secondary outcomes
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Time frame: At day 3
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Time frame: To Day 28
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Time frame: Day 56 to Day 196
Cumulative Probability of no PSA Failure From Day 28 to Day 196
Time frame: To Day 196
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame: To Day 196
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame: To Day 196
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 240/80 mg 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 7 inclusion and 15 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 12 Feb 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 12 Feb 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 Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 (time frame: Day 28 to Day 196). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2013.