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Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Plain-language guide to NCT02212197: phase 2 randomized trial of Leuprolide, 51 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02212197
- Phase
- phase 2
- Status
- completed
- Start
- 2014-09
- Completion (planned or actual)
- 2015-11
- Participants
- 51 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Leuprolide.
All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.
It had three arms (groups): one (experimental), one (experimental) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 51 actual participants took part.
It was open to men only aged from 40 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Men ≥40 and ≤85 years of age. Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy. Life expectancy over 12 months. World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2. Adequate and stable renal function.
The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: evidence of brain metastasis, spinal cord compression, or urinary tract obstruction; serum testosterone levels below 150 ng/dl at screening visit; medical or radiological prostate cancer treatments within 2 months prior to the screening visit.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.
The Leuprolide group and the comparison group ran side by side rather than switching.
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.
It started in 2014-09 with completion listed for 2015-11.
It ran at 7 sites in Finland (4) and Hungary (3).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP) and Mean Prostate Specific Antigen (PSA) Concentration.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Leuprolide in 51 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.