Active Surveillance for Low Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Active Surveillance Methodology for Low Risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146077
• Other study ID #: Sechenov-AS-19
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 2026

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2026
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University	Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy, Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	surgical treatment due to infravesical obstruction by BPH	Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy	5 years