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Plain-language guide to NCT00587431: phase 2 non-randomized trial of Leuprolide, 102 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00587431
- Phase
- phase 2
- Status
- completed
- Start
- 2003-07
- Completion (planned or actual)
- 2008-02
- Participants
- 102 (actual)
- Design
- non-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.
The researchers postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
It had two arms (groups): 1 (experimental) and 2 (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 102 actual participants took part.
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: Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC. Patient must have a serum testosterone \> 180 ng/dl. Patients must have adequate organ function as defined by the following. WBC \>\_ 3500/mm3. Platelet count \>100,000/mm3.
The full record lists 18 inclusion and 10 exclusion criteria; among the exclusions: uncontrolled serious active infection; anticipated survival of less than 3 months; active cns or epiduraltumor.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2003-07 with completion listed for 2008-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of Leuprolide in 102 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.