Prostate Metabolism, Cancer Risk and Gut Microbiota
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Observational
SUMMARY
This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Finland
Turku University Hospital
RECRUITING
Turku
University of Turku
RECRUITING
Turku
Contact Information
Primary
Peter J. Bostrom, MD, PhD
peter.bostrom@tyks.fi
+358-2-3135925
Backup
Tarja Lamminen, PhD
tarja.lamminen@tyks.fi
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 300
Treatments
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Turku
Leads: Turku University Hospital