Monitoring low-risk prostate cancer without immediate treatment
The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.
This study looks at how men with low-risk prostate cancer can be monitored over time without immediate treatment to understand how the disease progresses and how to best manage it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 462 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT00949819 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed adenocarcinoma of the prostate who have localized disease and have chosen active surveillance as their management plan.
Not a fit: Patients with advanced prostate cancer or those who are unwilling to undergo serial biopsies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management strategies for low-risk prostate cancer, potentially reducing unnecessary treatments.
How similar studies have performed: Previous studies on active surveillance for low-risk prostate cancer have shown promising results, indicating that this approach is gaining acceptance in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
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.