Leuprolide Acetate [amount hidden] Depot Injection for Patients With Advanced Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide.

Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria will be enrolled.

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

Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29.

Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29.

The registry classes the interventions as drug.

Who Took Part

The registry lists 155 actual participants took part.

It was open to men only aged from 18 years up to 99 years.

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

Examples of who could join: Male subjects aged above 18 years. Baseline Testosterone of \>1.50 ng/mL or \>150 ng/dL. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix 2). Life expectancy of at least 6 months from screening. Adequate organ and immune system function.

The full record lists 8 inclusion and 31 exclusion criteria; among the exclusions: evidence of brain metastases; evidence of spinal cord compression; undergone any prostate surgery (e.g. transurethral resection of the prostate (turp), radical prostatectomy) within two weeks of enrollment.

How the Study Was Run

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

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

The Leuprolide group and the comparison group ran side by side rather than switching.

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

It started in 2021-07-01 with completion listed for 2022-09-29.

It ran at 2 sites in India (2).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Testosterone response rate defined as Testosterone values sustained below castration level (0.5 ng/mL or 50 ng/dL) i.e. all Testosterone values at and after Day 28 until Day 57 must be < 0.5 ng/mL or < 50 ng/dL (time frame: From Day 28 to day 57).

It also tracked 9 secondary outcomes, for example Percentage of subjects who have reached castration level of Testosterone at the last visit (Day 57), Time after first implantation until castration level of Testosterone is achieved, Percentage of subjects with Testosterone values sustained below 0.2 ng/mL or 20 ng/dL at and after Day 28 until Day 57, Change from baseline in Luteinizing hormone (LH) levels at Day 28 and 57, Change from baseline in Follicle Stimulating Hormone (FSH) levels at Day 28 and Day 57 and Change from baseline in Prostate-specific antigen (PSA) at Day 57.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 155 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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