Active Surveillance for Low Risk Prostate Cancer
Recruiting · NCT04146077 · Observational (researchers observe without assigning treatment) · Lead sponsor: I.M. Sechenov First Moscow State Medical University
View the official record on ClinicalTrials.gov →What this trial is about
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.
Who can take part
Age range
50 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- prostate adenocarcinoma verified by at least 12 core biopsy
- patient must understand the sense of research, agree to participate and sign a form of agreement
- low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA\<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6)
- not more than 33% cores with adenocarcinoma
Exclusion criteria
- previous treatment of prostate cancer
- other prostatic malignant neoplasms
- other oncological diseases
- treatment with 5-alfa-reductase inhibitors
- patient's refuse to continue study
- patient's desire to begin treatment
Where it is running
1 location listed.
- Institute for Urology and Reproductive Health, Sechenov University. - Moscow, Russia