Prostate Metabolism, Cancer Risk and Gut Microbiota

NCT ID: NCT06116851

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-09-15

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.

Conditions

Prostate Cancer; Prostate Hyperplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

suspicion

Inclusion criteria for the suspicion 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.

The suspicion cohort will include a total of 300 subjects who will undergo PCa diagnostics including prostate MRI, and transrectal ultrasound (TRUS) guided prostate biopsies. After the diagnostic procedures all subjects are categorized to one of the following groups: 1) subject without PCa, 2) subject with clinically non-significant PCa (ISUP grade 1/Gleason 3+3), 3) clinically significant PCa (ISUP grade >1/>Gleason 3+3).

Based on the outcome of the PCa diagnostics and planned clinical treatment, subjects may be eligible to other cohorts as well.

MRI scan and laboratory visit

Intervention Type: OTHER

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.

Prostate biopsies

Intervention Type: PROCEDURE

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.

cancer (radical prostatectomy) cohort

Inclusion criteria for the cancer cohort include clinically significant prostate cancer planned to be treated with radical prostatectomy with or without pelvic lymph node dissection. The cancer cohort will include a total of 50 subjects.

Radical prostatectomy and blood, urine and tissue sampling

Intervention Type: PROCEDURE

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.

benign/TURP-cohort

Inclusion criteria for the benign (TURP) cohort includes benign prostate hyperplasia (BPH) planned to be treated with transurethral resection of the prostate (TURP). The benign/TURP-cohort will include a total of 50 subjects.

TURP and blood, urine and tissue sampling

Intervention Type: PROCEDURE

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.

benign/cystectomy

Inclusion criteria for the benign/cystectomy cohort includes bladder cancer planned to be treated with removal of the urinary bladder and prostate (cystoprostatectomy). The benign/cystectomy cohort will include a total of 25 subjects.

Radical cystoprostatectomy and blood, urine and tissue sampling

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter J. Bostrom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital and University of Turku

Locations

University of Turku

Turku, , Finland

Site Status: RECRUITING

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Peter J. Bostrom, MD, PhD

Role: CONTACT

peter.bostrom@tyks.fi

+358-2-3135925

Tarja Lamminen, PhD

Role: CONTACT

tarja.lamminen@tyks.fi

Facility Contacts

Peter J Bostrom, MD, PhD

Role: primary

peter.bostrom@tyks.fi

+358-2-3135925

Other Identifiers

15/1801/2022

Identifier Type: -

Identifier Source: org_study_id