Prostate Metabolism, Cancer Risk and Gut Microbiota

NCT06116851 | Recruiting

• 1 other identifier: 15/1801/2022
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Prostate Cancer; Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gut metabolomics

  immediately before prostate biopsy

Other Outcomes (2)

• Systemic circulation metabolomics

  immediately before prostate biopsy

• Prostate tissue metabolomics

  immediately before prostate biopsy

Study Arms (4)

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.

Other: MRI scan and laboratory visit; Procedure: Prostate biopsies

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.

Procedure: Radical prostatectomy and blood, urine and tissue sampling

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.

Procedure: TURP and blood, urine and tissue sampling

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.

Procedure: Radical cystoprostatectomy and blood, urine and tissue sampling

Interventions

MRI scan and laboratory visit 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.

suspicion

Prostate biopsies 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.

suspicion

Radical prostatectomy and blood, urine and tissue sampling 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.

cancer (radical prostatectomy) cohort

TURP and blood, urine and tissue sampling 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/TURP-cohort

Radical cystoprostatectomy and blood, urine and tissue sampling 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.

benign/cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (2)

University of Turku

Turku, 20100, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood and urine samples: Serum, plasma and whole blood samples will be collected to measure steroid hormone concentrations, global analysis of molecular lipids and polar metabolites, and for DNA sequence analysis. 2. Stool samples:Stool samples will be collected and stored in OMNImetGUT and OMNIgeneGUT and eSwab tubes. Samples will be used for sequencing and for antimicrobial susceptibility testing. 3. Tissue samples: Fresh frozen tissue samples will be collected from subjects going to surgery (TURP, RALP, Cystoprostatectomy) for sequencing and mass spec analysis.

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection; Urination; Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Peter J. Bostrom, MD, PhD

  Turku University Hospital and University of Turku

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J. Bostrom, MD, PhD

CONTACT

+358-2-3135925; peter.bostrom@tyks.fi

Tarja Lamminen, PhD

CONTACT

tarja.lamminen@tyks.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: November 3, 2023
• Study Start: June 1, 2022
• Primary Completion: January 15, 2024
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

FI (2)