Active Surveillance for Low Risk Prostate Cancer

NCT ID: NCT04146077

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Prostate Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role collaborator

Pirogov Russian National Research Medical University

OTHER

Sponsor Role collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dmitry Enikeev, MD, PhD

Deputy director for Research, Institute for Urology and Reproductive Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Dmitry Enikeev, MD, PhD

Role: primary

+7 925 517 79 26

Other Identifiers

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Sechenov-AS-19

Identifier Type: -

Identifier Source: org_study_id

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