Active Surveillance for Low Risk Prostate Cancer

Recruiting

• Conditions: Prostate Cancer; Prostate Adenocarcinoma

• Registration Number: NCT04146077
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2024-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cancer progression	5 years	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

Secondary Outcome Measures

Name	Time	Method
surgical treatment due to infravesical obstruction by BPH	5 years	Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy

Trial Locations

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University.; 🇷🇺 Moscow, Russian Federation