Prostate Cancer Clinical Trial
— ASCaPOfficial 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.
NCT number | NCT00949819 |
Other study ID # | 11-002281 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 4, 2009 |
Est. completion date | December 2028 |
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.
Status | Recruiting |
Enrollment | 462 |
Est. completion date | December 2028 |
Est. primary completion date | July 5, 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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 | Interim data analysis will be done each year |
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