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.
30 Years
85 Years
Male
Prostate Cancer
Trial Information
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 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
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
Type of Study:
Observational
Study Design:
Observational Model: Ecologic or Community, Time Perspective: Prospective
Outcome Measure:
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
Outcome Time Frame:
not specified
Safety Issue:
No
Principal Investigator
Leonard S Marks, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Los Angeles
Authority:
IRB, USA:
Study ID:
ASCaP
NCT ID:
NCT00949819
Start Date:
June 2009
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Low risk
- Gleason 6
- Active surveillance
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of California Los Angeles | Los Angeles, California 90095-6951 |
