Active Surveillance for Low Risk Prostate Cancer

I.M. Sechenov First Moscow State Medical University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Prostate Cancer Prostate Adenocarcinoma

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

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

Time frame: 5 years

Data from ClinicalTrials.gov

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