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A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Plain-language guide to NCT01220869: phase 3 interventional trial of Degarelix, 110 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01220869
- Phase
- phase 3
- Status
- completed
- Start
- 2010-12
- Completion (planned or actual)
- 2012-10
- Participants
- 110 (actual)
- Design
- na, 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
The trial (phase 3) is built around Degarelix.
It had 1 arm (groups): Degarelix (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 110 actual participants took part.
It was open to men only aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 20 years or older. Has a histological confirmed prostate cancer. Has a screening serum testosterone above 1.5 ng/mL. Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2. Has a screening PSA value of ≥2 ng/mL.
The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: current or previous hormone therapy; has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema; is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Degarelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-12 with completion listed for 2012-10.
It ran at 10 sites in Taiwan (10).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 (time frame: From Day 28 to Day 168).
It also tracked 3 secondary outcomes, for example Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3, Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28 and Cumulative Probability of no PSA Failure.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Degarelix in 110 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Degarelix compound page, all human trials.
Our Notes on the Compound
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.