A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.

What Was Tested

In this phase 4 trial, researchers set out to test Goserelin.

It had 1 arm (groups): Zoladex and Casodex (experimental).

The registry classes the interventions as drug.

More on the Plan

Neoadjuvant hormonal treatment (NHT) for clinically localised prostate cancer consists of complete androgen blockade (CAB) preceding either radiotherapy or surgery.

A large sample of 393 radical prostatectomy specimens were evaluated in 3 treatment groups, which were immediate surgery, 12 weeks of NHT (Zoladex and Casodex), and 24 weeks of NHT.

Patients included clinical stage B (T2a and T2b) and stage C (T3a and T3b).

Currently treatment of patients with oligometastatic prostate cancer is undergoing dramatic changes \[12\].

Who Took Part

Enrollment: 9 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Diagnosed within the past 12 months with T2DM according to 1999 WHO criteria. Men and women aged at least 18 years at screening. Either not received oral anti-diabetic drugs or had been on short-term (1 month) treatment that had been discontinued 3 months before enrolment. BMI≥18.5 kg/m2 and ≤ 45.0 kg/m2 . Able and willing to provide written informed consent and to comply with the study.

The full record lists 8 inclusion and 34 exclusion criteria; among the exclusions: diagnosis or history of:; acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state; diabetes insipidus.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2021-01-28 with completion listed for 2022-11-09.

It ran at 15 sites in China (15).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Resectability rate for primary tumour (the resectability will be assessed by central review using a digital rectal examination and confirmed by CT or MRI) (time frame: at 24 week).

It also tracked 11 secondary outcomes, for example Radical prostatectomy rate, The mean PSA by the end of NHT, Percentage of positive surgical margin for primary tumour, Incidence of seminal vesicle invasion, Percentage of pathological downstaging and surgical-related variables at 12 weeks, potent rates in erectile function at 12 weeks after surgery.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Goserelin in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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