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Active Surveillance for Low Risk Prostate Cancer

I

I.M. Sechenov First Moscow State Medical University

Status

Enrolling

Conditions

Prostate Adenocarcinoma
Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04146077
Sechenov-AS-19

Details and patient eligibility

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.

Enrollment

100 estimated patients

Sex

Male

Ages

50 to 75 years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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