Pharmacokinetics Pharmacodynamics and Safety of LY01022 in Patients With Prostate Cancer Compared With Zoladex® [amount hidden]

What Was Tested

The trial (phase 1) is built around Goserelin.

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

Blood samples will be collected to evaluate PK and PD profiles, and safety evaluation will be conducted as required in the protocol.

It had two arms (groups): LY01022 (experimental) and Zoladex® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 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: 18 years or older. Patients with locally advanced or metastatic prostate cancer suitable for endocrine therapy, including those who are suitable for endocrine therapy following radical therapy. Life expectancy of at least 9 months. ECOG score of ≤ 2. Total bilirubin (TBIL) ≤ 1.5×ULN, ALT and AST ≤ 3×ULN (or ≤ 5.0×ULN for patients with liver metastases).

The full record lists 10 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

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-05 with completion listed for 2023-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in plasma goserelin concentration after administration of LY01022 or Zoladex® (time frame: from baseline to Day 99).

It also tracked 4 secondary outcomes, for example Changes in serum testosterone concentration after administration of LY01022 or Zoladex®, Changes in serum luteinizing hormone (LH) concentration after administration of LY01022 or Zoladex®, Changes in serum follicle stimulating hormone (FSH) concentration after administration of LY01022 or Zoladex® and Adverse events throughout the study.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 24 people.

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

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.