Pharmacokinetics, Pharmacodynamics and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®

What Was Tested

In this phase 1 trial, researchers set out to test Goserelin.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, open-label, active-controlled phase I trial.

A total of 23 patients with locally advanced or metastatic prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 (±3d) before administration.

Blood samples were collected at the specified time points in the trial protocol to detect PK parameters of goserelin, and PD parameters (serum testosterone, LH and FSH).

Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) was conducted as required in the protocol.

Who Took Part

23 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. Life expectancy of at least 9 months. ECOG score of ≤ 2. Patients who voluntarily sign an IRB-approved informed consent form before any trial-related activities, are willing to abide by the restrictions of the study, and complete the prescribed examinations.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: patients with confirmed or suspected hormone-resistant prostate cancer; patients who have previously received hypophysectomy or adrenalectomy, or who have pituitary lesions or adrenal dysfunction; history of severe asthma, anaphylaxis, or severe urticaria and/or angioedema.

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 2021-02-04 with completion listed for 2021-09-15.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 16 secondary outcomes, for example Percentage changes compared to baseline in serum FSH level after each administration, Percentage changes compared to baseline in serum LH level after each administration and Adverse events throughout the study.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 23 people.

Its size is small, so on its own it can only give an early look.

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.