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Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448
Plain-language guide to NCT01132404: phase 1, phase 2 randomized trial of Leuprolide, 9 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01132404
- Phase
- phase 1, phase 2
- Status
- terminated early
- Start
- 2010-11
- Completion (planned or actual)
- 2011-09
- Participants
- 9 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer; Prostatic Neoplasms
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1, phase 2 trial tested Leuprolide.
It had three arms (groups): one (experimental), one (experimental) and Leuprorelin (active comparator).
The registry classes the interventions as drug.
Who Took Part
9 actual participants took part.
It was open to men only aged from 40 years up to 72 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male 40 to 72 years of age. Histologically-confirmed adenocarcinoma of the prostate having completed primary local treatment at least 6 months prior to screening. Meet all laboratory evaluation values at screening as specified in protocol. Generally fit medical condition, with no acute or chronic medical conditions other than prostate cancer, affecting 2-year life expectancy. Ability to understand and comply with protocol requirements.
The full record lists 10 inclusion and 18 exclusion criteria; among the exclusions: advanced or symptomatic metastatic prostate cancer requiring immediate gnrh or additional hormone therapy or requiring chemotherapy; history of surgical castration; history of nonskin cancer, other than prostate cancer, requiring active treatment within 2 years of screening.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.
The Leuprolide group and the comparison group ran side by side rather than switching.
Being open-label, the Leuprolide study did not mask who received what.
It started in 2010-11 with completion listed for 2011-09.
It ran at 1 site in France.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 2 secondary outcomes, for example For Phase 2 portion of study: to assess the effect of 1-month depot TAK-448 on serum prostate specific antigen (PSA) concentration.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of Leuprolide in 9 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.