Prostate Metabolism, Cancer Risk and Gut Microbiota

Prostate Cancer Clinical Trial

— PROMIC  

Official title:

Prostate Metabolism, Cancer Risk and Gut Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116851
• Other study ID #: 15/1801/2022
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 15, 2026

Study information

• Verified date: October 2023
• Source: Turku University Hospital
• Contact: Peter J. Bostrom, MD, PhD
• Phone: +358-2-3135925
• Email: peter.bostrom[@]tyks.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.

Description:

Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common male cancer in Finland and most western countries. Interestingly, although the incidence of indolent (latent) PCa is very similar throughout the globe, there is a remarkable global age-adjusted incidence variation (up to 40-fold difference between highest and lowest incidences).

Epidemiological data suggest that aging in men is associated with neoplastic processes in the prostate but only a subset of men will develop a true malignancy potentially affecting their life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the mechanisms mediating protective or harmful effects of life-style remain unclear.

Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, has been acknowledged to play significant role in many metabolic pathways and pathogenetic processes in the human body. Although there is some evidence suggesting that gut microbiota affects therapy responses (especially androgen deprivation) in PCa, it´s potential role in prostate carcinogenesis is not well documented. Our previous studies suggest that gut microbiota composition is different in men with and without PCa potentially contributing to the Pca risk, and that changes in steroid hormone synthesis may be one mechanism how gut microbiota affects PCa risk.

PROMIC is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and PCa. The main aim is to validate our preliminary findings of association between gut microbiota and PCa. We also study metabolic characteristics in the gut, systemic circulation, and prostate tissue in men with different gut microbiota signatures. The study is carried out in Turku University Hospital and University of Turku.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 15, 2026
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form.

• Ability and stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

• inability to comply with study procedures or unwillingness to participate in the study.

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Cancer
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

Other:
• MRI scan and laboratory visit
Prostate MRI scan is performed according to the protocol used in earlier studies (PMID 31158230). In addition to the PCa diagnostics, the scan will include abdominal imaging to body composition analysis (visceral and subcutaneous fat and psoas muscle). Baseline blood and urine samples are collected in Turku University Hospital laboratory.

Procedure:
• Prostate biopsies
The visit follows routine outpatient clinic protocol. The results from MRI and laboratory findings are discussed and the potential benefits and harms from prostate biopsies are evaluated. After a mutual decision, prostate biopsies are performed.
• Radical prostatectomy and blood, urine and tissue sampling
Baseline blood and urine samples are collected at the time of surgery. Robotic assisted laparoscopic prostatectomy (RALP) is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.
• TURP and blood, urine and tissue sampling
Baseline blood and urine samples are collected the time of surgery. TURP is performed according to normal protocol. Routine diagnostic histopathological procedures will be followed in the department of pathology. Additionally, tissue samples (a total of 10 resection chips) will be collected for study analyses. Due to the study, no additional tissue samples are removed, i.e. study samples are from the tissues removed as clinically indicated.
• Radical cystoprostatectomy and blood, urine and tissue sampling
Baseline blood and urine samples are collected at the time of surgery. Radical cystoprostatectomy is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku
Finland	University of Turku	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systemic circulation metabolomics	Metabolic characteristics in the systemic circulation in men with different gut microbiota signatures	immediately before prostate biopsy
Other	Prostate tissue metabolomics	Metabolic characteristics in the prostate tissue in men with different gut microbiota signatures	immediately before prostate biopsy
Primary	Gut microbiota signature	Gut microbiota signature in men with clinically significant prostate cancer, clinically non-significant prostate cancer, and benign prostate histology	immediately before prostate biopsy
Secondary	Gut metabolomics	Metabolic characteristics in the gut in men with different gut microbiota signatures	immediately before prostate biopsy