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Search / Trial NCT04146077

Active Surveillance for Low Risk Prostate Cancer

Launched by I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY · Oct 28, 2019

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Prostate Cancer Active Surveillance Low Oncological Risk

ClinConnect Summary

This clinical trial is focused on monitoring men with low-risk prostate cancer to see how well we can keep track of the disease without immediate treatment. The study will use several tests, like blood tests (PSA), physical exams (DRE), and imaging scans (MRI), to check for any changes in the cancer over time. The goal is to ensure that if the cancer starts to progress, we catch it early so that treatment can be started when necessary.

To participate in this trial, you need to be a man aged 18 to 90 who has been diagnosed with low-risk prostate cancer based on specific criteria, such as having a certain type of cancer confirmed by a biopsy and a low PSA level. You should not have had previous treatments for prostate cancer or other serious cancers. If you join, you can expect regular check-ups and tests to monitor your condition, and you'll be asked to agree to participate in the study by signing a consent form. This study is actively recruiting participants, and your involvement could help improve how we manage low-risk prostate cancer in the future.

Gender

MALE

Eligibility criteria

  • 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

About I.M. Sechenov First Moscow State Medical University

i.m. Sechenov First Moscow State Medical University is a prestigious institution dedicated to advancing medical education, research, and clinical practice. As a leading center for medical innovation in Russia, the university fosters a collaborative environment for scientific inquiry and the development of novel therapies. With a commitment to high-quality clinical trials, i.m. Sechenov aims to contribute significantly to the global biomedical landscape by evaluating new treatments and improving patient care through rigorous research methodologies and ethical standards.

Locations

Moscow, , Russian Federation

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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