Active Surveillance for Low Risk Prostate Cancer

ConditionsProstate Cancer Prostate Adenocarcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age50-75

SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

previous treatment of prostate cancer

other prostatic malignant neoplasms

other oncological diseases

treatment with 5-alfa-reductase inhibitors

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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

Time frame

5 years

Secondary outcomes

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

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

I.M. Sechenov First Moscow State Medical University

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Collaborator

Pirogov Russian National Research Medical University