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Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Plain-language guide to NCT00056654: not phased non-randomized trial of Leuprolide, 164 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00056654
- Phase
- not phased
- Status
- completed
- Start
- 2003-03
- Completion (planned or actual)
- 2004-07
- Participants
- 164 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostatic Neoplasms
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Leuprolide.
It had 1 arm (groups): 1 (experimental).
The registry classes the interventions as drug.
Who Took Part
164 actual participants took part.
It was open to men only.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Histological diagnosis of prostate cancer. Need for androgen deprivation treatment for 1 year. Serum testosterone level ≥ 150 ng/dL. Life expectancy of at least 18 months. ECOG Performance status grades 0,1 or 2.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: hypersensitivity to leuprolide acetate or polylactic acid; history of bilateral orchiectomy, adrenalectomy, or hypophysectomy; history of hypogonadism.
How the Study Was Run
Design: non-randomized, single-group and open-label.
Being open-label, the Leuprolide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2003-03 with completion listed for 2004-07.
It ran at 55 sites in United States (55).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects (time frame: Day 32 through Week 52).
It also tracked 4 secondary outcomes, for example Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status, Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty), Change from baseline in prostate specific antigen (PSA) and Change from baseline in prostatic acid phosphatase (PAP).
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Leuprolide in 164 people.
The trial is marked completed; 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.