Actively Recruiting

Age: 50Years - 75Years
MALE
NCT04146077

Active Surveillance for Low Risk Prostate Cancer

Led by I.M. Sechenov First Moscow State Medical University · Updated on 2021-07-22

100

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

Sponsors

I

I.M. Sechenov First Moscow State Medical University

Lead Sponsor

M

Moscow Regional Research and Clinical Institute (MONIKI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Active Surveillance for Low Risk Prostate Cancer

Who Can Participate

Age: 50Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Prostate adenocarcinoma confirmed by at least 12 core biopsy
  • Patient understands the study and agrees to participate by signing consent
  • Low oncological risk as per EAU Guidelines: stage T1-T2a, PSA less than 10 ng/ml, ISUP score 1 (Gleason score 3+3=6)
  • No more than 33% of biopsy cores contain adenocarcinoma
Not Eligible

You will not qualify if you...

  • Previous treatment for prostate cancer
  • Other malignant prostate tumors
  • Other cancer diseases
  • Treatment with 5-alpha-reductase inhibitors
  • Patient refuses to continue in the study
  • Patient wants to begin treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, Russia, 119991

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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