Active Surveillance for Low Risk Prostate Cancer

NCT04146077 | Recruiting

• 1 other identifier: Sechenov-AS-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

prostate cancer; active surveillance; low oncological risk

Outcome Measures

Primary Outcomes (1)

• cancer progression

  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

  5 years

Secondary Outcomes (1)

• surgical treatment due to infravesical obstruction by BPH

  5 years

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with low risk prostate cancer, who gave informed consent to undergo active surveillance and to participate in this study, and had no previous treatment of prostate cancer or surgery at the prostate.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• Moscow Regional Research and Clinical Institute (MONIKI): collaborator
• Pirogov Russian National Research Medical University: collaborator

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director for Research, Institute for Urology and Reproductive Health

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

RU (1)