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One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
Plain-language guide to NCT01744366: phase 3 randomized trial of Goserelin and Degarelix, 285 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01744366
- Phase
- phase 3
- Status
- completed
- Start
- 2013-01
- Completion (planned or actual)
- 2015-05
- Participants
- 285 (actual)
- 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
This registered phase 3 trial tested Goserelin and Degarelix.
One month degarelix/comparator treatment for prostate cancer in Chinese population.
It had two arms (groups): Degarelix (experimental) and Goserelin (active comparator).
The registry classes the interventions as drug.
Who Took Part
285 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: Chinese male over 18 years. Adenocarcinoma of the prostate. Relevant disease status based on lab values and as judged by the physician. Life expectancy of at least a year.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: previous hormonal treatment for prostate cancer; considered to be candidate for curative therapy; has received an investigational drug within the last 28 days and no previous treatment with degarelix.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Goserelin group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.
It started in 2013-01 with completion listed for 2015-05.
It ran at 29 sites in China (29).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) (time frame: Day 28 to Day 364).
It also tracked 8 secondary outcomes, for example Proportion of patients with testosterone levels ≤0.5 ng/mL, Percentage change in prostate-specific antigen (PSA), Changes in testosterone and PSA levels, Frequency and severity of adverse events and Cumulative probability of no PSA failure.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Goserelin and Degarelix in 285 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Goserelin compound page and the Degarelix compound page, all human trials.
Our Notes on the Compounds
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.
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.