Prostate CancerIMPRINTNCT04638049
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)
A study testing Collection of human biofluids and Patient reported outcome measures in people with Prostate Cancer and Prostate Adenocarcinoma, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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" … Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms
- What is being tested?
- Collection of human biofluids and Patient reported outcome measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Aug 2020to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT): A Prospective Biomarker Study
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).
Read the 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.
- Being tested
- Collection of human biofluids, Patient reported outcome measures
- Keywords
- Radiotherapy, Microbiome, Metabolome
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of human biofluidsOther
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 measuresOther
EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Collection of human biofluids; Other: Patient reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome profiles as assessed by fecal samples
Characterization of dynamic changes in the intestinal microbiota composition using 16S rRNA sequencing technology
Measured: 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)
Measured: Up to 3.5 months after inclusion
Secondary outcomes (5)
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
Measured: Up to 3.5 months after inclusion
Incidence of GI and Genitourinary (GU) toxicities
GI and GU toxicities as per Common Terminology for Adverse Events (CTCAE) v4.0
Measured: Up to 3.5 months after inclusion
Patient reported QOL as per EORTC-QLQ C30
Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Measured: Up to 3.5 months after inclusion
Patient reported QOL as per EORTC-QLQ PR25
Validated questionnaire assessing the health-related QOL of prostate cancer patients
Measured: Up to 3.5 months after inclusion
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
Measured: Up to 3.5 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start25 Aug 2020
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piet Ost, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638049
- Sponsor's protocol ID
- BC-07902
- Acronym
- IMPRINT
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT): A Prospective Biomarker Study
- ClinicalTrials.gov ID
- NCT04638049
- Acronym / sponsor ID
- IMPRINT / BC-07902
- Keywords
- Radiotherapy, Microbiome, Metabolome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate (Bed) only RadioTherapy (PBRT) | Active comparator | Other: Collection of human biofluids, Other: Patient reported outcome measuresPrimary, 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. |
| Whole Pelvis RadioTherapy (WPRT) | Active comparator | Other: Collection of human biofluids, Other: Patient reported outcome measuresPrimary, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of human biofluidsFeces, blood and urine: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT | Other | Prostate (Bed) only RadioTherapy (PBRT), Whole Pelvis RadioTherapy (WPRT) |
| Patient reported outcome measuresEORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT | Other | Prostate (Bed) only RadioTherapy (PBRT), Whole Pelvis RadioTherapy (WPRT) |
Primary outcome
Microbiome profiles as assessed by fecal samples
Time frame: Up to 3.5 months after inclusion
Characterization of dynamic changes in the intestinal microbiota composition using 16S rRNA sequencing technology
Metabolome profiles as assessed by fecal, blood and urine samples
Time frame: Up to 3.5 months after inclusion
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)
5 secondary outcomes
Discovery of potential predictive biomarkers for the development of RT-induced GI toxicities
Time frame: Up to 3.5 months after inclusion
Incidence of GI and Genitourinary (GU) toxicities
Time frame: Up to 3.5 months after inclusion
Patient reported QOL as per EORTC-QLQ C30
Time frame: Up to 3.5 months after inclusion
Patient reported QOL as per EORTC-QLQ PR25
Time frame: Up to 3.5 months after inclusion
Concentration of BEVs in fecal and blood samples
Time frame: Up to 3.5 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piet Ost, MD, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of human biofluids and Patient reported outcome measures in people with Prostate Cancer and Prostate Adenocarcinoma, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome profiles as assessed by fecal samples (time frame: Up to 3.5 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.