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Efficacy and Safety Study of ELIGARD [amount hidden] With Prostate Cancer
Plain-language guide to NCT01511874: phase 4 interventional trial of Leuprolide, 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01511874
- Phase
- phase 4
- Status
- completed
- Start
- 2011-01
- Completion (planned or actual)
- 2013-05
- Participants
- 42 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Leuprolide.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
42 actual participants took part.
It was open to men only aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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.
The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: hormone-refractory prostate cancer; brain metastasis; another primary malignant tumor except for prostate cancer.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-01 with completion listed for 2013-05.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Ratio of subjects whose blood testosterone concentration is maintained below [amount hidden]/dl at 4 weeks after injection of ELIGARD [amount hidden].
It also tracked 9 secondary outcomes, for example Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks, Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks, Change in self assessment scale grade, Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks, Change in ECOG performance status and Change in blood prostate-specific antigen.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Leuprolide in 42 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.