Active Surveillance for Low Risk Prostate Cancer

Active Surveillance Methodology for Low Risk Prostate Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04146077

Enrollment

100

Registered

2019-10-31

Start date

2019-10-01

Completion date

2026-10-31

Last updated

2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma, Prostate Cancer

Keywords

prostate cancer, active surveillance, low oncological risk

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
cancer progression	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

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

Countries

Russia

Outcome results