Clinical trial NCT06116851: Prostate Metabolism, Cancer Risk and Gut Microbiota
Official title: Prostate Metabolism, Cancer Risk and Gut Microbiota
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Prostate Hyperplasia
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2023-11-03
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Suspicion cohort: cohort include clinical suspicion for PCa and indication for PCA diagnostics based on any of the following: 1) elevated PSA (\>2.5 ng/ml), 2) palpable prostate tumor/nodule, 3) image finding suggestive of PCa.

Cancer cohort, (RALP): cohort include clinically significant prostate cancer planned to be treated with radical prostatectomy with or without pelvic lymph node dissection.

TURP cohort: cohort includes benign prostate hyperplasia (BPH) planned to be treated with transurethral resection of the prostate (TURP).

Cystectomy cohort: cohort includes bladder cancer planned to be treated with removal of the urinary bladder and prostate (cystoprostatectomy).

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiota signature
timeFrame: immediately before prostate biopsy
Secondary outcomes:
measure: Gut metabolomics
timeFrame: immediately before prostate biopsy
Other outcomes:
measure: Systemic circulation metabolomics
timeFrame: immediately before prostate biopsy
measure: Prostate tissue metabolomics
timeFrame: immediately before prostate biopsy
Locations:
city: Turku
country: Finland
facility: University of Turku
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital and University of Turku
name: Peter J. Bostrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: