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Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

Plain-language guide to NCT03860987: phase 2 interventional trial of Goserelin, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03860987
Phase
phase 2
Status
completed
Start
2019-04-30
Completion (planned or actual)
2026-05-11
Participants
12 (actual)
Design
na, open label (everyone knows who gets what), diagnostic
Conditions studied
Castrate Sensitive Prostate Cancer
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery.

It had 1 arm (groups): 1 (experimental).

Treatment.

The registry classes the interventions as drug and procedure.

Who Took Part

12 actual participants took part.

It was open to men only aged from 18 years up to 99 years.

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

Examples of who could join: Intermediate risk (patient must have at least one of the features listed below):. PSA level is between 10 and 20 ng/ml,. Gleason score is 7, OR. Stage T2b or T2c,. High risk (patient must have at least one of the features listed below):.

The full record lists 28 inclusion and 20 exclusion criteria; among the exclusions: patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day prior to registration); patients with evidence of distant metastatic disease beyond n1 (regional) lymph nodes on conventional imaging studies (e.g., ct, mri or bone scan); history of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide, abiraterone or other agents used in study.

How the Study Was Run

The set-up was single-group and open-label.

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 2019-04-30 with completion listed for 2026-05-11.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): disease status (time frame: 2 months).

It also tracked 1 secondary outcome, for example pathological complete response rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 12 people.

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

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.

Our Notes on the Compound

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.