Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06116851
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostate Metabolism, Cancer Risk and Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014554', 'term': 'Urination'}, {'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.\n2. 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.\n3. Tissue samples: Fresh frozen tissue samples will be collected from subjects going to surgery (TURP, RALP, Cystoprostatectomy) for sequencing and mass spec analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Systemic circulation metabolomics', 'timeFrame': 'immediately before prostate biopsy', 'description': 'Metabolic characteristics in the systemic circulation in men with different gut microbiota signatures'}, {'measure': 'Prostate tissue metabolomics', 'timeFrame': 'immediately before prostate biopsy', 'description': 'Metabolic characteristics in the prostate tissue in men with different gut microbiota signatures'}], 'primaryOutcomes': [{'measure': 'Gut microbiota signature', 'timeFrame': 'immediately before prostate biopsy', 'description': 'Gut microbiota signature in men with clinically significant prostate cancer, clinically non-significant prostate cancer, and benign prostate histology'}], 'secondaryOutcomes': [{'measure': 'Gut metabolomics', 'timeFrame': 'immediately before prostate biopsy', 'description': 'Metabolic characteristics in the gut in men with different gut microbiota signatures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.', 'detailedDescription': '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).\n\nEpidemiological 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.\n\nGut 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.\n\nPROMIC 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nCancer cohort, (RALP): cohort include clinically significant prostate cancer planned to be treated with radical prostatectomy with or without pelvic lymph node dissection.\n\nTURP cohort: cohort includes benign prostate hyperplasia (BPH) planned to be treated with transurethral resection of the prostate (TURP).\n\nCystectomy cohort: cohort includes bladder cancer planned to be treated with removal of the urinary bladder and prostate (cystoprostatectomy).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Ability and stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* inability to comply with study procedures or unwillingness to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06116851', 'acronym': 'PROMIC', 'briefTitle': 'Prostate Metabolism, Cancer Risk and Gut Microbiota', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Prostate Metabolism, Cancer Risk and Gut Microbiota', 'orgStudyIdInfo': {'id': '15/1801/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'suspicion', 'description': '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.\n\nThe 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).\n\nBased on the outcome of the PCa diagnostics and planned clinical treatment, subjects may be eligible to other cohorts as well.', 'interventionNames': ['Other: MRI scan and laboratory visit', 'Procedure: Prostate biopsies']}, {'label': 'cancer (radical prostatectomy) cohort', 'description': '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.', 'interventionNames': ['Procedure: Radical prostatectomy and blood, urine and tissue sampling']}, {'label': 'benign/TURP-cohort', 'description': '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.', 'interventionNames': ['Procedure: TURP and blood, urine and tissue sampling']}, {'label': 'benign/cystectomy', 'description': '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.', 'interventionNames': ['Procedure: Radical cystoprostatectomy and blood, urine and tissue sampling']}], 'interventions': [{'name': 'MRI scan and laboratory visit', 'type': 'OTHER', '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.', 'armGroupLabels': ['suspicion']}, {'name': 'Prostate biopsies', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['suspicion']}, {'name': 'Radical prostatectomy and blood, urine and tissue sampling', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['cancer (radical prostatectomy) cohort']}, {'name': 'TURP and blood, urine and tissue sampling', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['benign/TURP-cohort']}, {'name': 'Radical cystoprostatectomy and blood, urine and tissue sampling', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['benign/cystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Peter J Bostrom, MD, PhD', 'role': 'CONTACT', 'email': 'peter.bostrom@tyks.fi', 'phone': '+358-2-3135925'}, {'name': 'Antti Salminen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Peter J. Boström, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Peter J. Bostrom, MD, PhD', 'role': 'CONTACT', 'email': 'peter.bostrom@tyks.fi', 'phone': '+358-2-3135925'}, {'name': 'Tarja Lamminen, PhD', 'role': 'CONTACT', 'email': 'tarja.lamminen@tyks.fi'}], 'overallOfficials': [{'name': 'Peter J. Bostrom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital and University of Turku'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}