Active Surveillance for Low Risk Prostate Cancer

July 21, 2021 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

Active Surveillance Methodology for Low Risk Prostate Cancer

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Recruiting
        • Institute for Urology and Reproductive Health, Sechenov University.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with low risk prostate cancer, who gave informed consent to undergo active surveillance and to participate in this study, and had no previous treatment of prostate cancer or surgery at the prostate.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer progression
Time Frame: 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
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Collaborators

Pirogov Russian National Research Medical University
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2026

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sechenov-AS-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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