Ghent University Hospital investigates the Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity
University Hospital, Ghent is starting a new clinical trial of Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT).
Radiotherapy (RT) of the abdomen and/or pelvis is known to cause acute and late gastrointestinal (GI) toxicities. While radiation dose and volume are known risk factors for developing such side effects, recent evidence suggests patterns of disturbance in the composition of the GI microbiota - so called "dysbiosis" - may also promote the host's susceptibility to GI toxicities through impaired intestinal barrier function and inflammation. The IMPRINT-study aims to expand the current knowledge on the role of intestinal bacteria and their metabolites involved in the pathophysiology of radiation-induced GI toxicities by longitudinally examining the microbiota composition, the associated metabolome and bacterial extracellular vesicles (BEVs).
The IMPRINT-study is a study assessing the impact of different treatment field sizes and associated radiation doses on the patient's microbiome and metabolome, whereby the link with radiation-induced GI toxicities will be emphasized.
The clinical trial started in August 25, 2020 and will continue throughout March 17, 2023.
There are a number of conditions that allow participation, such as:
- Histologically proven (initial) adenocarcinoma of the prostate
- Localized and/or regional disease stage at diagnosis
- RT is an integral part of the treatment - primary, adjuvant or salvage
- WHO performance status 0-2
- Administration of androgen deprivation therapy (ADT) before RT
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Ghent University Hospital, Ghent, Belgium, 9000 is the location of clinical trial.
Ghent University Hospital (Universitair Ziekenhuis Gent; UZ Gent) is one of the largest hospitals in Belgium. It is closely linked to Ghent University, the university's rector also being the hospital's president. Both the university and the hospital are autonomous entities of the Flemish Government.
Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT04638049
