RecruitingObservational

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.

NCT ID: NCT00949819Sponsor: Jonsson Comprehensive Cancer CenterLast updated: 2026-05-26

Summary

Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.

Detailed description

This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following: * Imaging studies of the prostate * Rates of curative intervention * Measures of tumor recurrence/progression * Disease specific survival * Overall survival * Clinical data to track Quality of Life

Arms & interventions

OtherActive surveillance
Serial, long term data collection and active surveillance

Outcome measures

Primary

Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
Time frame: Interim data analysis will be made every year

Secondary

Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention
Time frame: Interim data analysis will be done each year

Eligibility criteria

Sex: MaleAge: 30 Years to 85 YearsHealthy volunteers: No

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

Study locations (1)

University of California Los Angeles

Los Angeles, California, 90095

Recruiting

Leonard S Marks, M.D. · Principal Investigator

References

Martin SC, Gonzalez S, Kwan L, Delfin M, Nguyen AV, Brisbane W, Felker E, Sisk A, Priester A, Natarajan S, Marks LS. Evolution of Active Surveillance of Prostate Cancer: Impact of Magnetic Resonance Imaging, Magnetic Resonance Imaging-Guided Biopsy, and Focal Therapy. J Urol. 2025 Aug;214(2):177-187. doi: 10.1097/JU.0000000000004559. Epub 2025 Apr 21.(PubMed)