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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04146077
Other study ID # Sechenov-AS-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 2026

Study information

Verified date July 2021
Source I.M. Sechenov First Moscow State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 2026
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 75 Years
Eligibility 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

Study Design


Locations

Country Name City State
Russian Federation Institute for Urology and Reproductive Health, Sechenov University. Moscow

Sponsors (3)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy, Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary cancer progression Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy 5 years
Secondary surgical treatment due to infravesical obstruction by BPH Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy 5 years
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