Clinical trial NCT04638049: Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)
Official title: Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT): A Prospective Biomarker Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostatic Neoplasms
Keywords: Radiotherapy
Microbiome
Metabolome
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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 (feces), the associated metabolome (blood, feces and urine) and bacterial extracellular vesicles (BEVs) (blood and feces).

Detailed description: The IMPRINT-study is a prospective biomarker 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. Blood, urine and fecal samples will be longitudinally collected at 4 different time points: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT. To our knowledge, this is the first clinical research project relating the impact of multiple radiation parameters on fecal-, urine- and blood-based biomarkers to risk of GI toxicities in a homogeneously defined study population.

Eligibility criteria: Inclusion Criteria:

* Histologically proven (initial) adenocarcinoma of the prostate
* Localized (confined to primary site) and/or regional (spread to regional pelvic lymph nodes) disease stage at diagnosis
* Age ≥ 18 years
* 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
* Signed informed consent form (ICF) according to ICH/GCP and national/regional regulations

Exclusion Criteria:

* Other primary tumor (except for non-melanoma skin cancer) diagnosed \< 5 years before enrollment
* Diagnosis of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis)
* Administration of systemic therapy during RT other that ADT
* Subjected to antibiotic treatment or medically imposed dietary restrictions \< 1 month prior to enrollment
* Body mass index (BMI) \> 35
* Administration of pelvic RT \< 1 year

Primary outcomes:
measure: Microbiome profiles as assessed by fecal samples
timeFrame: Up to 3.5 months after inclusion
measure: Metabolome profiles as assessed by fecal, blood and urine samples
timeFrame: Up to 3.5 months after inclusion
Secondary outcomes:
measure: Discovery of potential predictive biomarkers for the development of RT-induced GI toxicities
timeFrame: Up to 3.5 months after inclusion
measure: Incidence of GI and Genitourinary (GU) toxicities
timeFrame: Up to 3.5 months after inclusion
measure: Patient reported QOL as per EORTC-QLQ C30
timeFrame: Up to 3.5 months after inclusion
measure: Patient reported QOL as per EORTC-QLQ PR25
timeFrame: Up to 3.5 months after inclusion
measure: Concentration of BEVs in fecal and blood samples
timeFrame: Up to 3.5 months after inclusion
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Ghent
name: Piet Ost, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: