Active Surveillance for Low Risk Prostate Cancer

I.M. Sechenov First Moscow State Medical University

Status: Enrolling

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04146077

Sechenov-AS-19

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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