Active Surveillance for Low Risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Prostate Adenocarcinoma. Basic parameters: 50 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Active Surveillance Methodology for Low Risk Prostate Cancer
Overview
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.
Primary outcome measures
- cancer progression [Time frame: 5 years]
Secondary outcome measures (1)
- surgical treatment due to infravesical obstruction by BPH [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Institute for Urology and Reproductive Health, Sechenov University. — Moscow
Identifiers
NCT: NCT04146077 · Sechenov-AS-19