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Recruiting

NCT Number: NCT04146077

Active Surveillance 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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenocarcinoma Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

Location status: Recruiting

Location contact

Dmitry Enikeev, MD, PhD

CONTACT

[email protected]

+7 925 517 79 26

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Collaborators

  • Moscow Regional Research and Clinical Institute (MONIKI)
  • Pirogov Russian National Research Medical University

Registry information

Official study title

Active Surveillance Methodology for Low Risk Prostate Cancer

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Oct 31, 2019
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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