Active Surveillance for Low Risk Prostate Cancer

Sponsor

I.M. Sechenov First Moscow State Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04146077

Collaborator

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

100

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Adenocarcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Active Surveillance Methodology for Low Risk Prostate Cancer

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2026

Outcome Measures

Primary Outcome Measures

cancer progression [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

Secondary Outcome Measures

surgical treatment due to infravesical obstruction by BPH [5 years]
Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Urology and Reproductive Health, Sechenov University.	Moscow		Russian Federation	119991

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dmitry Enikeev, MD, PhD, Deputy director for Research, Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University

ClinicalTrials.gov Identifier:

NCT04146077

Other Study ID Numbers:

Sechenov-AS-19

First Posted:

Oct 31, 2019

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dmitry Enikeev, MD, PhD, Deputy director for Research, Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University

prostate cancer

active surveillance

low oncological risk

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jul 22, 2021