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Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
Plain-language guide to NCT01442246: phase 3 randomized trial of Leuprolide, 700 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01442246
- Phase
- phase 3
- Status
- active, not recruiting
- Start
- 2011-07
- Completion (planned or actual)
- 2027-09
- Participants
- 700 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Metastases
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Leuprolide.
SECONDARY OBJECTIVE(S): * PSA evolution * Evaluation of testosterone level * Specific survival * Overall survival * Tolerance * Quality of life (QLQ-C30 questionnaires).
It had two arms (groups): Adjuvant treatment (experimental) and Surveillance (no intervention).
Leuproreline acetate.
Surveillance.
The registry classes the interventions as drug.
Who Took Part
700 planned participants were the target.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients who have received the information leaflet and signed the consent form. ≥18 years of age with a life expectancy of at least 10 years. Performance Status (ECOG) ≤2. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion. Histologically confirmed prostatic adenocarcinoma.
The full record lists 13 inclusion and 10 exclusion criteria; among the exclusions: previous treatments for prostatic adenocarcinoma (ht or orchiectomy or ct); presence of metastases:; positive bone scintigraphy, including patients with medullary compression and/or.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Leuprolide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.
It started in 2011-07 with completion listed for 2027-09.
It ran at 35 sites in France (35).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Leuprolide in 700 people.
With 700 participants it is a large trial for this field.
Its status is active not recruiting; 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.