To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer.

It had two arms (groups): Zo-LY (other) and LY-Zo (other).

The registry classes the interventions as drug.

More on the Plan

Androgen Deprivation Therapy (ADT) is an important systemic therapy for prostate cancer, which plays a vital role in the treatment of various stages of prostate cancer.

Gonadotropin-releasing hormone (GnRH) agonists are the most commonly used ADT treatment，including leuprolide, goserelin, and triptorelin.

The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.

Who Took Part

60 planned participants were the target.

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: Male patients older than 18 years. Histologically confirmed prostate adenocarcinoma. Suitable for ADT treatment. Prior treatment without GnRH agonists. Expected survival \>1 year.

The full record lists 14 inclusion and 4 exclusion criteria; among the exclusions: prior treatment with zoladex, ly01005 or other gnrh agonists, while gnrh agonists for \< 6 months and discontinued for more than 6 months were allowed; diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions; any medical conditions that the investigators believe make the patient ineligible to participate in the study.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Goserelin and the comparison in turn, acting as their own control.

Being open-label, the Goserelin study did not mask who received what.

It started in 2024-05 with completion listed for 2025-05.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Patient preference (time frame: Assessed up 16 weeks after randomization).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.