Prostate Cancer Clinical Trial
— IMPRINTOfficial title:
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT): A Prospective Biomarker Study
NCT number | NCT04638049 |
Other study ID # | BC-07902 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 25, 2020 |
Est. completion date | August 8, 2022 |
Verified date | October 2020 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | August 8, 2022 |
Est. primary completion date | August 8, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbiome profiles as assessed by fecal samples | Characterization of dynamic changes in the intestinal microbiota composition using 16S rRNA sequencing technology | Up to 3.5 months after inclusion | |
Primary | Metabolome profiles as assessed by fecal, blood and urine samples | Characterization of dynamic changes in the concentration of all small molecules (metabolites) in feces, blood and urine using ultra-high performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS) | Up to 3.5 months after inclusion | |
Secondary | Discovery of potential predictive biomarkers for the development of RT-induced GI toxicities | The identified microbiota and metabolite signatures will be investigated for association with incidence and severity of GI toxicities | Up to 3.5 months after inclusion | |
Secondary | Incidence of GI and Genitourinary (GU) toxicities | GI and GU toxicities as per Common Terminology for Adverse Events (CTCAE) v4.0 | Up to 3.5 months after inclusion | |
Secondary | Patient reported QOL as per EORTC-QLQ C30 | Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients | Up to 3.5 months after inclusion | |
Secondary | Patient reported QOL as per EORTC-QLQ PR25 | Validated questionnaire assessing the health-related QOL of prostate cancer patients | Up to 3.5 months after inclusion | |
Secondary | Concentration of BEVs in fecal and blood samples | BEVs in fecal and blood samples will be separated and analyzed through the orthogonal implementation of ultrafiltration, size-exclusion chromatography (SEC) and density-gradient centrifugation, followed by biochemical characterization | Up to 3.5 months after inclusion |
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