Prostate Metabolism, Cancer Risk and Gut Microbiota

Trial Title: Prostate Metabolism, Cancer Risk and Gut Microbiota

NCT ID: NCT06116851

Condition: Prostate Cancer
Prostate Hyperplasia

Conditions: Official terms:
Prostatic Hyperplasia
Hyperplasia

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: MRI scan and laboratory visit
Description: 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.
Arm group label: suspicion

Intervention type: Procedure
Intervention name: Prostate biopsies
Description: 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.
Arm group label: suspicion

Intervention type: Procedure
Intervention name: Radical prostatectomy and blood, urine and tissue sampling
Description: 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.
Arm group label: cancer (radical prostatectomy) cohort

Intervention type: Procedure
Intervention name: TURP and blood, urine and tissue sampling
Description: 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.
Arm group label: benign/TURP-cohort

Intervention type: Procedure
Intervention name: Radical cystoprostatectomy and blood, urine and tissue sampling
Description: 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.
Arm group label: benign/cystectomy

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.

Criteria for eligibility:

Study pop:
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).

Sampling method: Probability Sample
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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Turku

Address:
City: Turku
Zip: 20100
Country: Finland

Status: Recruiting

Contact:
Last name: Peter J Bostrom, MD, PhD

Phone: +358-2-3135925
Email: peter.bostrom@tyks.fi

Investigator:
Last name: Antti Salminen, MD
Email: Sub-Investigator

Facility:
Name: Turku University Hospital

Address:
City: Turku
Country: Finland

Status: Recruiting

Investigator:
Last name: Peter J. Boström, MD, PhD
Email: Principal Investigator

Start date: June 1, 2022

Completion date: September 15, 2026

Lead sponsor:
Agency: Turku University Hospital
Agency class: Other

Collaborator:
Agency: University of Turku
Agency class: Other

Source: Turku University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06116851