Prostate CancerPROMICNCT06116851
Prostate Metabolism, Cancer Risk and Gut Microbiota
An observational study of Prostate Cancer and Prostate Hyperplasia, run by Turku University Hospital at 2 sites in Finland.
Trial summary
This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Hyperplasia
- What is being tested?
- MRI scan and laboratory visit, Prostate biopsies and Radical prostatectomy and blood, urine and tissue sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Jun 2022to 15 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- inability to comply with study procedures or unwillingness to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Tarja Lamminen, PhD contact
Finland2 sites, 2 recruiting
- Recruiting
University of Turku
Turku, 20100
Peter J Bostrom, MD, PhD, +358-2-3135925, peter.bostrom@tyks.fi
Antti Salminen, MD
- Recruiting
Turku University Hospital
Turku
Peter J. Boström, MD, PhD
About this study
This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.
Read the 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
- Being tested
- MRI scan and laboratory visit, Prostate biopsies, Radical prostatectomy and blood, urine and tissue sampling, TURP and blood, urine and tissue sampling, Radical cystoprostatectomy and blood, urine and tissue sampling
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scan and laboratory visitOther
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 biopsiesProcedure or 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 samplingProcedure or 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 samplingProcedure or 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 samplingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Radical cystoprostatectomy and blood, urine and tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota signature
Gut microbiota signature in men with clinically significant prostate cancer, clinically non-significant prostate cancer, and benign prostate histology
Measured: immediately before prostate biopsy
Secondary outcomes (1)
Gut metabolomics
Metabolic characteristics in the gut in men with different gut microbiota signatures
Measured: immediately before prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Jun 2022
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Peter J. Bostrom, MD, PhD, Principal investigator, Turku University Hospital and University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116851
- Sponsor's protocol ID
- 15/1801/2022
- Acronym
- PROMIC
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Metabolism, Cancer Risk and Gut Microbiota
- ClinicalTrials.gov ID
- NCT06116851
- Acronym / sponsor ID
- PROMIC / 15/1801/2022
- Conditions
- Prostate Cancer, Prostate Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| suspicion | – | Other: MRI scan and laboratory visit, Procedure: Prostate biopsiesInclusion 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. |
| cancer (radical prostatectomy) cohort | – | Procedure: Radical prostatectomy and blood, urine and tissue samplingInclusion 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. |
| benign/TURP-cohort | – | Procedure: TURP and blood, urine and tissue samplingInclusion 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. |
| benign/cystectomy | – | Procedure: Radical cystoprostatectomy and blood, urine and tissue samplingInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- inability to comply with study procedures or unwillingness to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scan and laboratory visitProstate 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. | Other | suspicion |
| Prostate biopsiesThe 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. | Procedure or surgery | suspicion |
| Radical prostatectomy and blood, urine and tissue samplingBaseline 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. | Procedure or surgery | cancer (radical prostatectomy) cohort |
| TURP and blood, urine and tissue samplingBaseline 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. | Procedure or surgery | benign/TURP-cohort |
| Radical cystoprostatectomy and blood, urine and tissue samplingBaseline 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. | Procedure or surgery | benign/cystectomy |
Primary outcome
Gut microbiota signature
Time frame: immediately before prostate biopsy
Gut microbiota signature in men with clinically significant prostate cancer, clinically non-significant prostate cancer, and benign prostate histology
1 secondary outcome
Gut metabolomics
Time frame: immediately before prostate biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarja Lamminen, PhD contact
Peter J. Bostrom, MD, PhD principal investigator
Turku University Hospital and University of Turku
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Hyperplasia, run by Turku University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter J. Bostrom, MD, PhD (+358-2-3135925, peter.bostrom@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota signature (time frame: immediately before prostate biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.