Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)

What Was Tested

The trial (phase 2) is built around Leuprolide.

This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma.

Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.

It had two arms (groups): Abiraterone acetate + prednisone + leuprolide + cabazitaxel (experimental) and Abiraterone acetate + prednisone + leuprolide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 76 actual participants took part.

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: Willing and able to provide informed consent;. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a minimum of 3 cores positive for tumour;. Tumour biopsy tissue accessible for downstream evaluation;. Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation;. High Risk D'Amico score defined as either PSA \> 20, Gleason score ≥ 8 as determined by the local pathologist; or T2c-3 based on DRE, pathologic review +/- imaging;.

The full record lists 15 inclusion and 9 exclusion criteria; among the exclusions: received an investigational agent within 4 weeks prior to screening;; stage t4 prostate cancer by clinical examination or radiologic evaluation;; hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2016-09 with completion listed for 2021-05-27.

It ran at 5 sites in Canada (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathological complete response (time frame: 24 weeks from start of treatment).

It also tracked 15 secondary outcomes, for example Pre-operative PSA levels, Mean nadir PSA levels, Percentage of participants achieving a PSA < 0.2 ng/mL, Rate of positive surgical margins, Rate of near-complete response (<5 mm tumour) and Rate of extracapsular extension.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 76 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.