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Active Surveillance for Low Risk Prostate Cancer

RECRUITINGSponsored by I.M. Sechenov First Moscow State Medical University
Actively Recruiting
SponsorI.M. Sechenov First Moscow State Medical University
Started2019-10-01
Est. completion2024-10
Eligibility
Age50 Years – 75 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04146077

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.

Eligibility

Age: 50 Years – 75 YearsSex: MALEHealthy volunteers accepted
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

Conditions3

CancerProstate AdenocarcinomaProstate Cancer

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