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Goserelin [amount hidden] Injection in Treatment of Advanced Prostate Cancer
Plain-language guide to NCT03936218: phase 3 randomized trial of Goserelin, 94 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03936218
- Phase
- phase 3
- Status
- completed
- Start
- 2020-09-30
- Completion (planned or actual)
- 2023-11-30
- Participants
- 94 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Advanced Prostate Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Goserelin.
It had two arms (groups): Inj. Goserelin (Test) Subcutaneously (experimental) and Inj. Zoladex (Reference) Subcutaneously (active comparator).
The registry classes the interventions as drug.
More on the Plan
Each patient will have 25 visits total.
Total duration of the study will be 183 days (including up to 14 days of screening).
Who Took Part
94 actual participants took part.
It was open to men only aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male patient with age of 18 to 75 years (Both inclusive). Body mass index (BMI) between 18.5 and 30 kg/m². (Both inclusive). Patient must be able to give informed consent for participation in the trial. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Adequate bone marrow function, renal function, liver function.
The full record lists 13 inclusion and 25 exclusion criteria; among the exclusions: evidence of severe urinary tract obstruction with anticipated urinary retention, in the opinion of the investigator, taking into account medical history, clinical observations and symptoms; patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin; patients who are already on gnrh receptor agonist or antagonist therapy directed for prostate cancer.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.
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 2020-09-30 with completion listed for 2023-11-30.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Goserelin in 94 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, all human trials.
Our Notes on the Compound
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
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.