Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®

What Was Tested

The trial (phase 3) is built around Goserelin.

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

The registry classes the interventions as drug.

More on the Plan

A total of 290 patients with prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 before administration.

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

Who Took Part

290 actual participants took part.

It was open to men only aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 50 years or older. Life expectancy of at least 9 months. ECOG score of ≤ 2. Total bilirubin (TBIL) ≤ 1.5×ULN, both ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases) at the screening visit. Patients who voluntarily sign an IRB-approved informed consent form before the screening visit, are willing to abide by the restrictions of the study, and complete the prescribed examinations.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: has received prostatic surgery within 4 weeks prior to the screening visit, or plan to receive surgical treatment during the trial; patients with confirmed or suspected hormone-resistant prostate cancer; has previously received hypophysectomy or adrenalectomy, or who have pituitary lesions.

How the Study Was Run

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

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

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 2020-01-06 with completion listed for 2021-03-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The cumulative percentage of subjects with the maintenance of serum testosterone ≤[amount hidden]/dL ([amount hidden]/L) from Day 29 to Day 85.

It also tracked 10 secondary outcomes, for example Percentage changes compared to baseline in serum LH level after administration, Changes in serum LH level after administration, Percentage changes compared to baseline in serum FSH level after administration, Changes in serum FSH level after administration, Percentage changes compared to baseline in serum PSA level after administration and Changes in serum PSA level after administration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 290 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.