Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

What Was Tested

This registered phase 2 trial tested Goserelin.

It had two arms (groups): ADT and Abiraterone (experimental) and ADT, Abiraterone and Apalutamide (experimental).

The registry classes the interventions as drug.

Who Took Part

64 actual participants took part.

It was open to men only aged from 18 years up to 80 years.

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

Examples of who could join: Histologic confirmed prostatic adenocarcinoma. Non-castrate levels of testosterone (\> 150 ng/dL). Tumor stage T3 by digital rectal examination, or. Primary tumor Gleason score ≥ 8, or. PSA ≥ 20 ng/mL.

The full record lists 15 inclusion and 7 exclusion criteria; among the exclusions: pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate; evidence of metastatic disease (m1) on imaging studies; other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

In this single-blind Goserelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-01-24 with completion listed for 2022-04-30.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic response (time frame: 3 months).

It also tracked 6 secondary outcomes, for example Residual cellularity rate, Pathologic downgrading, PSA decline rate, Rate of positive surgical margins, Rate of undetectable PSA and Rate of Grade ≥ 3 CTCAE adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 64 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.