NCT04146077
Recruiting
N/A
Active Surveillance Methodology for Low Risk Prostate Cancer
I.M. Sechenov First Moscow State Medical University1 site in 1 country100 target enrollmentOctober 1, 2019
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- I.M. Sechenov First Moscow State Medical University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- cancer progression
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Dmitry Enikeev, MD, PhD
Deputy director for Research, Institute for Urology and Reproductive Health
I.M. Sechenov First Moscow State Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- surgical treatment due to infravesical obstruction by BPH(5 years)
Study Sites (1)
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