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

NCT04638049 | Completed

• 1 other identifier: BC-07902
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostatic Neoplasms

Keywords

Radiotherapy; Microbiome; Metabolome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Discovery of potential predictive biomarkers for the development of RT-induced GI toxicities

  Up to 3.5 months after inclusion

• Incidence of GI and Genitourinary (GU) toxicities

  Up to 3.5 months after inclusion

• Patient reported QOL as per EORTC-QLQ C30

  Up to 3.5 months after inclusion

• Patient reported QOL as per EORTC-QLQ PR25

  Up to 3.5 months after inclusion

• Concentration of BEVs in fecal and blood samples

  Up to 3.5 months after inclusion

Study Arms (2)

Prostate (Bed) only RadioTherapy (PBRT)

ACTIVE COMPARATOR

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.

Other: Collection of human biofluids; Other: Patient reported outcome measures

Whole Pelvis RadioTherapy (WPRT)

ACTIVE COMPARATOR

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.

Other: Collection of human biofluids; Other: Patient reported outcome measures

Interventions

Collection of human biofluids OTHER

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

Prostate (Bed) only RadioTherapy (PBRT); Whole Pelvis RadioTherapy (WPRT)

Patient reported outcome measures OTHER

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

Prostate (Bed) only RadioTherapy (PBRT); Whole Pelvis RadioTherapy (WPRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Piet Ost, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 20, 2020
• Study Start: August 25, 2020
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: December 1, 2022

Record last verified: 2020-10

Locations

BE (1)