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Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide
Plain-language guide to NCT01344564: not phased non-randomized trial of Leuprolide and Degarelix, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01344564
- Phase
- not phased
- Status
- completed
- Start
- 2011-04
- Completion (planned or actual)
- 2012-08
- Participants
- 50 (actual)
- Design
- non-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
In this not phased trial, researchers set out to test Leuprolide and Degarelix.
The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone.
The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.
It had 1 arm (groups): ADT (other).
All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 50 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: 18 years or older. Histologically confirmed adenocarcinoma of the prostate. Androgen deprivation therapy is indicated.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: baseline screening serum testosterone \<150ng/dl; eastern cooperative oncology group (ecog) score \> 2; diagnosed spinal or brain metastases.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
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 2011-04 with completion listed for 2012-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Testosterone measurement (time frame: 11 times over 6 months).
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Leuprolide and Degarelix in 50 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 and the Degarelix compound page, all human trials.
Our Notes on the Compounds
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.
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.