Actively Recruiting
Active Surveillance Methodology for Low Risk Prostate Cancer
Led by I.M. Sechenov First Moscow State Medical University · Updated on 2021-07-22
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
I.M. Sechenov First Moscow State Medical University
Lead Sponsor
M
Moscow Regional Research and Clinical Institute (MONIKI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are observing men diagnosed with low-risk prostate cancer to monitor their condition over time without immediate treatment. The study focuses on using active surveillance methods to watch for any signs that the cancer may be progressing. This approach follows guidelines for patients with early-stage prostate cancer characterized by low PSA levels and specific biopsy results. The monitoring involves regular prostate-specific antigen (PSA) testing, digital rectal examinations (DRE), transrectal ultrasounds (TRUS), magnetic resonance imaging (MRI), and follow-up biopsies. These tools help detect any changes in the cancer status promptly. The study tracks participants over a five-year period to evaluate cancer progression and any need for surgical treatment due to prostate enlargement causing urinary obstruction. Participants will undergo these assessments at scheduled intervals to provide detailed information about their prostate health. Researchers will use the gathered data to measure cancer progression and the occurrence of surgical interventions related to benign prostatic hyperplasia (BPH). The study participation may last up to five years, during which safety and disease status are closely observed.
CONDITIONS
Brief Title
Active Surveillance for Low Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 50 to 75 years
- Prostate adenocarcinoma confirmed by at least 12 core biopsy
- Low oncological risk according to European Association of Urology Guidelines: stage T1-T2a, PSA less than 10 ng/ml, Gleason score 3+3=6
- No more than 33% of biopsy cores contain adenocarcinoma
- Patient understands the study, agrees to participate, and signs informed consent
You will not qualify if you...
- Previous treatment for prostate cancer
- Presence of other prostatic malignant tumors
- Other cancer diseases
- Treatment with 5-alpha-reductase inhibitors
- Patient refuses to continue in the study
- Patient wishes to begin active treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time to monitor the progression of low risk prostate cancer without active treatment.
Regular monitoring visits as per study schedule
Trial Site Locations
Total: 1 location
1
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia, 119991
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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