Active Surveillance for Cancer of the Prostate (ASCaP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active surveillance.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 30 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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
Interventions
- Other Active surveillance
Serial, long term data collection and active surveillance
Primary outcome measures
- 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 outcome measures (1)
- 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
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostate.
- Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
- No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
- Patient has elected Active Surveillance as preferred management plan for prostate cancer.
- Patient consent has been obtained according to local Institutional Review Board .
- Patient is accessible and compliant for follow-up.
Exclusion criteria
- Unwillingness or inability to undergo serial prostate biopsy.
- Overall life expectancy less than 2 years
- Advanced prostate cancer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
United States · 1 center
- University of California Los Angeles — Los Angeles
Publications
- 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. PMID 40257918
Identifiers
NCT: NCT00949819 · 11-002281