Prostate CancerPhase 4NCT01511874
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
A Phase 4 study testing ELIGARD 22.5mg in people with Prostate Cancer, run by HanAll BioPharma Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects 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?
- ELIGARD 22.5mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male of 20 years or above
- Subject with prostate cancer with TNM stage T2~4NxMx
- Blood testosterone concentration ≥ 100ng/dl
- Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
- WHO ECOG performance status ≤ 2
- Signed written informed consent
Who cannot join
- Hormone-Refractory Prostate cancer
- Brain metastasis
- Another primary malignant tumor except for prostate cancer
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Seoul
About this study
Official title: Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- ELIGARD 22.5mg
- Keywords
- ELIGARD, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIGARD 22.5mgDrug
Also called ELIGARD
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
| Study group | Role | What they receive |
|---|---|---|
| ELIGRAD 22.5mg | Experimental | a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks Receives: Drug: ELIGARD 22.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
Measured: 4weeks
Secondary outcomes (9)
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks
Measured: 24weeks
Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks
Measured: 24weeks
Change in self assessment scale grade
Measured: 0,4, 8, 12, 24 weeks
Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks
Measured: 4, 24 weeks
Change in ECOG performance status
Measured: 0,4,8,12, 24weeks
Change in blood prostate-specific antigen
Measured: 0,4,8,12,24 weeks
Change in QoL_EPIC grade
Measured: 0,12, 24weeks
Change in penile length
Measured: screening, 12, 24weeks
Change in testicular volume
Measured: screening, 12, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung Ha Chung, Medicine, Principal investigator, Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511874
- Sponsor's protocol ID
- fr-HE530-01
- Status last verified
- Sep 2015
- First submitted
- 13 Jan 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01511874
- Acronym / sponsor ID
- fr-HE530-01
- Conditions
- Prostate Cancer
- Keywords
- ELIGARD, Prostate cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects 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 |
|---|---|---|
| ELIGRAD 22.5mg | Experimental | Drug: ELIGARD 22.5mga subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks |
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)
- Male of 20 years or above
- Subject with prostate cancer with TNM stage T2~4NxMx
- Blood testosterone concentration ≥ 100ng/dl
- Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
- WHO ECOG performance status ≤ 2
Key exclusion criteria (4 listed)
- Hormone-Refractory Prostate cancer
- Brain metastasis
- Another primary malignant tumor except for prostate cancer
- Other conditions which in the opinion of the investigator preclude enrollment into the study
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 |
|---|---|---|
| ELIGARD 22.5mgAlso: ELIGARDa subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks | Drug | ELIGRAD 22.5mg |
Primary outcome
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
Time frame: 4weeks
9 secondary outcomes
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks
Time frame: 24weeks
Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks
Time frame: 24weeks
Change in self assessment scale grade
Time frame: 0,4, 8, 12, 24 weeks
Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks
Time frame: 4, 24 weeks
Change in ECOG performance status
Time frame: 0,4,8,12, 24weeks
Change in blood prostate-specific antigen
Time frame: 0,4,8,12,24 weeks
Change in QoL_EPIC grade
Time frame: 0,12, 24weeks
Change in penile length
Time frame: screening, 12, 24weeks
Change in testicular volume
Time frame: screening, 12, 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Byung Ha Chung, Medicine principal investigator
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ELIGARD 22.5mg in people with Prostate Cancer, run by HanAll BioPharma Co., Ltd. at 1 site 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 6 inclusion and 4 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg (time frame: 4weeks). 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 23 Sep 2015.