Clinical trial · Interventional
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)
Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT): A Prospective Biomarker Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of human biofluids | Other | — | UNRESOLVED |
| Patient reported outcome measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prostate (Bed) only RadioTherapy (PBRT)
- 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.
- interventionNames
- Other: Collection of human biofluids
- Other: Patient reported outcome measures
- type
- ACTIVE_COMPARATOR
- label
- Whole Pelvis RadioTherapy (WPRT)
- 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.
- interventionNames
- Other: Collection of human biofluids
- Other: Patient reported outcome measures
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available