Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)

NCT ID: NCT04638049

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2022-08-08

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostatic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Prostate (Bed) only RadioTherapy (PBRT)

Primary, adjuvant or salvage RT of the prostate (bed) without RT of the pelvic nodal regions in the small pelvis, according to local hospital guidelines and protocols.

Group Type: ACTIVE_COMPARATOR

Collection of human biofluids

Intervention Type: OTHER

Feces, blood and urine: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT

Patient reported outcome measures

Intervention Type: OTHER

EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT

Whole Pelvis RadioTherapy (WPRT)

Primary, adjuvant or salvage RT of the pelvic nodal regions in the small pelvis with possible additional RT of the prostate (bed), according to local hospital guidelines and protocols.

Group Type: ACTIVE_COMPARATOR

Collection of human biofluids

Intervention Type: OTHER

Feces, blood and urine: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT

Patient reported outcome measures

Intervention Type: OTHER

EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT

Interventions

Collection of human biofluids

Feces, blood and urine: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT

Intervention Type: OTHER

Patient reported outcome measures

EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piet Ost, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BC-07902

Identifier Type: -

Identifier Source: org_study_id