Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

What Was Tested

The trial (phase 2) is built around Goserelin.

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa.

It had two arms (groups): ADT with Abiraterone and prednisone (experimental) and ADT alone (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 75 planned participants were the target.

It was open to men only aged from 18 years up to 75 years.

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

Examples of who could join: Patients must be ≥ 18 and ≤75 years of age. All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1. Patients must have adequate renal function, within 28 days prior to registration, as evidenced by serum creatinine ≤2×ULN.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible; patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible; patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2019-04-01 with completion listed for 2021-03-01.

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 (time frame: up to 8 months). Proportion of Subjects With Minimal Residual Disease (time frame: up to 8 months).

It also tracked 8 secondary outcomes, for example Rate of Stage Degradation, Rate of Positive Surgical Margins, Rate of Complete Serum Remission, Proportion of subjects without PSA progression, Imaging Response Rate and Recovery time of urinary continence (day).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 75 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.