Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

It had 1 arm (groups): ADT with Abiraterone and prednisone (experimental).

The registry classes the interventions as drug.

More on the Plan

The primary endpoint is the pathologic complete response (pCR).

Who Took Part

50 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: Age ≥ 18 years. Histologically or cytologically diagnosis of prostate cancer with positive IDC-P status. High-risk localized prostate cancer, defined by either: Tumor stage ≥T3a by digital rectal examination, or Primary tumor Gleason score ≥ 8, or PSA \> 20 ng/mL. No evidence of metastases. The ECOG score of the patient is ≤2.

The full record lists 17 inclusion and 14 exclusion criteria; among the exclusions: prior androgen deprivation therapy (medical or surgical), radiation therapy or chemotherapy for prostate cancer; evidence of metastatic disease (m1) on imaging studies; pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate.

How the Study Was Run

It was run as a single-group and open-label study.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-05 with completion listed for 2022-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic Complete Response Rate（pCR） (time frame: 6 months).

It also tracked 11 secondary outcomes, for example Rate of Subjects With Minimal Residual Disease, Rate of positive surgical margin (PSM), Rate of Nodal Metastases After 6 Months of Treatment, Rate of Pathologic T3 Disease After 6 Months of Treatment, Biochemical Progression-free Survival (bPFS) and PSA decline rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 50 people.

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.