Monitoring low-risk prostate cancer without immediate treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational protocol focuses on men with low-risk, localized prostate cancer, specifically those with Gleason 6 tumors. Participants will be monitored over time to collect clinical data and specimens, assessing factors such as imaging results, rates of curative interventions, tumor progression, and quality of life. Unlike traditional clinical trials, this study does not involve randomization or treatment interventions, but rather aims to gather valuable information on the natural progression of the disease. The goal is to better understand how to manage prostate cancer in patients who choose active surveillance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
3. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
4. Patient has elected Active Surveillance as preferred management plan for prostate cancer.
5. Patient consent has been obtained according to local Institutional Review Board .
6. Patient is accessible and compliant for follow-up.

Exclusion Criteria:

1. Unwillingness or inability to undergo serial prostate biopsy.
2. Overall life expectancy less than 2 years
3. Advanced prostate cancer

Where it's running

• University of California Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Leonard S Marks, M.D. — University of California, Los Angeles
• Study coordinator: Malu Macairan
• Email: mmacairan@mednet.ucla.edu
• Phone: (310) 794-3566

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.