Monitoring low-risk prostate cancer without immediate treatment
Active Surveillance Methodology for Low Risk Prostate Cancer
I.M. Sechenov First Moscow State Medical University · NCT04146077
This study is testing if closely monitoring men with low-risk prostate cancer without immediate treatment can safely manage their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | Male |
| Sponsor | I.M. Sechenov First Moscow State Medical University (other) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04146077 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with low-risk prostate cancer, utilizing a protocol of active surveillance. Participants will undergo regular monitoring through PSA testing, digital rectal examinations, transrectal ultrasounds, MRIs, and follow-up biopsies to track any progression of the cancer. The aim is to determine the effectiveness of this approach in managing low-risk cases without immediate intervention. The study is designed to ensure that patients are closely observed while minimizing unnecessary treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are men diagnosed with low-risk prostate adenocarcinoma who meet specific clinical criteria.
Not a fit: Patients with a history of prostate cancer treatment or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients avoid overtreatment and its associated side effects while still effectively monitoring their cancer.
How similar studies have performed: Other studies have shown success with active surveillance approaches for low-risk prostate cancer, indicating that this method is both viable and beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow
- Institute for Urology and Reproductive Health, Sechenov University. — Moscow, Russia (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Prostate Adenocarcinoma, prostate cancer, active surveillance, low oncological risk