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

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Collection of human biofluids
Patient reported outcome measures
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring Radiotherapy, Microbiome, Metabolome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prostate (Bed) only RadioTherapy (PBRT)

Whole Pelvis RadioTherapy (WPRT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Microbiome profiles as assessed by fecal samples
Characterization of dynamic changes in the intestinal microbiota composition using 16S rRNA sequencing technology
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)

Secondary Outcome Measures

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
Incidence of GI and Genitourinary (GU) toxicities
GI and GU toxicities as per Common Terminology for Adverse Events (CTCAE) v4.0
Patient reported QOL as per EORTC-QLQ C30
Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Patient reported QOL as per EORTC-QLQ PR25
Validated questionnaire assessing the health-related QOL of prostate cancer patients
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

Full Information

First Posted
October 30, 2020
Last Updated
November 30, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04638049
Brief Title
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)
Acronym
IMPRINT
Official Title
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT): A Prospective Biomarker Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms
Keywords
Radiotherapy, Microbiome, Metabolome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate (Bed) only RadioTherapy (PBRT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Whole Pelvis RadioTherapy (WPRT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Collection of human biofluids
Intervention Description
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
Intervention Name(s)
Patient reported outcome measures
Intervention Description
EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT
Primary Outcome Measure Information:
Title
Microbiome profiles as assessed by fecal samples
Description
Characterization of dynamic changes in the intestinal microbiota composition using 16S rRNA sequencing technology
Time Frame
Up to 3.5 months after inclusion
Title
Metabolome profiles as assessed by fecal, blood and urine samples
Description
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)
Time Frame
Up to 3.5 months after inclusion
Secondary Outcome Measure Information:
Title
Discovery of potential predictive biomarkers for the development of RT-induced GI toxicities
Description
The identified microbiota and metabolite signatures will be investigated for association with incidence and severity of GI toxicities
Time Frame
Up to 3.5 months after inclusion
Title
Incidence of GI and Genitourinary (GU) toxicities
Description
GI and GU toxicities as per Common Terminology for Adverse Events (CTCAE) v4.0
Time Frame
Up to 3.5 months after inclusion
Title
Patient reported QOL as per EORTC-QLQ C30
Description
Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Time Frame
Up to 3.5 months after inclusion
Title
Patient reported QOL as per EORTC-QLQ PR25
Description
Validated questionnaire assessing the health-related QOL of prostate cancer patients
Time Frame
Up to 3.5 months after inclusion
Title
Concentration of BEVs in fecal and blood samples
Description
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
Time Frame
Up to 3.5 months after inclusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piet Ost, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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