Health TrialsbyHealthPanel

Prostate Metabolism, Cancer Risk and Gut Microbiota

ConditionsProstate CancerProstate Hyperplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorTurku University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRI scan and laboratory visit

    Other intervention

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: suspicion2 interventions
Group B: cancer (radical prostatectomy) cohort1 intervention
Group C: benign/TURP-cohort1 intervention
Group D: benign/cystectomy1 intervention

Trial outcomes

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

Time frame
immediately before prostate biopsy

Secondary outcomes

1

Gut metabolomics

Metabolic characteristics in the gut in men with different gut microbiota signatures

Time frame
immediately before prostate biopsy

Other outcomes

1

Systemic circulation metabolomics

Metabolic characteristics in the systemic circulation in men with different gut microbiota signatures

Time frame
immediately before prostate biopsy
2

Prostate tissue metabolomics

Metabolic characteristics in the prostate tissue in men with different gut microbiota signatures

Time frame
immediately before prostate biopsy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

University of Turku

Collaborator

Source ClinicalTrials.gov
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