Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)

What Was Tested

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

A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI).

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

The registry classes the interventions as drug and radiation.

More on the Plan

Prostate cancer (PCa) is the most frequent diagnosed malignancy in male patients in Europe and radiation therapy (RT) is a main treatment option.

For primary high-risk localized PCa patients, NCCNv4.2023 guidelines recommend normo- or hypofractionated RT to the prostate ± the elective pelvic lymphatics and systemic treatment in terms of ADT.

The aim of this prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on MMAI.

Thus, the safety and oncologic outcome results of this study might be the first in this highly selected treatment group: NCCN high-risk, PSMA PET cN0/cM0 and MMAI high-risk.

Who Took Part

The registry lists 30 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: Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI). High- or very high-risk according to NCCNv1.2023 criteria. Signed written informed consent for this study. Age \>18 years. Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: prior radiotherapy to the prostate or pelvis; prior radical prostatectomy; prior focal therapy approaches to 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 2024-09-16 with completion listed for 2027-08-31.

It ran at 1 site in Cyprus.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: cumulative GU toxicity (time frame: two years).

It also tracked 22 secondary outcomes, for example Time to local or regional failure, MMAI classifier, Testosterone, Metastatic free survival (MFS), Overall Survival (OS) and Prostate cancer specific survival (PCSS).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 30 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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