← Human Trials & Peer-Reviewed Studies
Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
Plain-language guide to NCT00375687: not phased randomized trial of Triptorelin, 61 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00375687
- Phase
- not phased
- Status
- status unknown
- Start
- 2005-08
- Completion (planned or actual)
- 2020-01
- Participants
- 61
- Design
- randomized, 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
In this not phased trial, researchers set out to test Triptorelin.
The registry classes the interventions as drug.
More on the Plan
The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients.
Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment).
Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.
Who Took Part
The registry lists 61 planned participants were the target.
It was open to men only aged from 40 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Postoperative PSA \>0.2 ng/ml. Gleason \> 7. Signated infomed consent.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: neoadjuvant hormonaltherapy before rp; R1 RP; N+ RP.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2005-08 with completion listed for 2020-01.
It ran at 1 site in Lithuania.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Survival.
It also tracked 2 secondary outcomes, for example PSA dinamics and quality of life.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Triptorelin in 61 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, all human trials.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
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.