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Recruiting

Active Surveillance for Cancer of the Prostate (ASCaP)

NCT00949819 · Jonsson Comprehensive Cancer Center
In plain English

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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.
About this study
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
Eligibility 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
Study design
Enrollment target: 462 participants
Age groups: adult, older_adult
Timeline
Starts: 2009-07-04
Estimated completion: 2028-12
Last updated: 2026-05-26
Interventions
Other: Active surveillance
Primary outcomes
  • Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. (Interim data analysis will be made every year)
Sponsor
Jonsson Comprehensive Cancer Center · other
Contacts & investigators
ContactMalu Macairan · contact · mmacairan@mednet.ucla.edu · (310) 794-3566
ContactLeonard S Marks, M.D. · contact · lmarks@mednet.ucla.edu · (310) 794-3070
InvestigatorLeonard S Marks, M.D. · principal_investigator, University of California, Los Angeles
All locations (1)
University of California Los AngelesRecruiting
Los Angeles, California, United States
Active Surveillance for Cancer of the Prostate (ASCaP) · TrialPath