Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer

What Was Tested

The trial (phase 1, phase 2) is built around Goserelin.

It had 1 arm (groups): Hypofractionated EBRT plus HDR-BT boost (other).

Primarily hypofractionated EBRT consisting of 12 x 3 Gy/fraction, TD 36 Gy will be administered. Followed by HDR-BT boost of the prostate, TD 14 Gy.

The registry classes the interventions as drug and radiation.

Who Took Part

Enrollment: 40 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: The patient must consent to be in the study and must have signed an approved consent form. Age \> 18 years old. Life expectancy of at least five years, excluding his diagnosis of prostate cancer. Histopathologically proven primary adenocarcinoma of the prostate. The patient must be registered within 180 days following the histopathological confirmation of the malignancy.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: histopathological confirmation or suspicion in conventional or molecular imaging of regional or distant metastases; prior pelvic radiotherapy; known autoimmune disorders (e.g. inflammatory bowel disease, lupus, scleroderma).

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

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

It started in 2021-08-01 with completion listed for 2022-12-31.

It ran at 1 site in Cyprus.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity (time frame: up to 2 years).

It also tracked 6 secondary outcomes, for example Rate of biochemical control, Rate of overall survival, Rate of prostate cancer-specific survival, Rate of distant metastasis-free survival and 18F-PSMA PET/CT Vs conventional imaging for identification of pelvic nodal or distant secondaries.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Goserelin in 40 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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