Active Surveillance for Cancer of the Prostate (ASCaP)
ASCaP
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.
1 other identifier
observational
462
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2009
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 13, 2025
May 1, 2025
18 years
July 29, 2009
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (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
Interim data analysis will be done each year
Study Arms (1)
no treatment
Men with previously untreated, early stage prostate cancer.
Interventions
Eligibility Criteria
Community sample
You may qualify if:
- 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.
You may not qualify if:
- Unwillingness or inability to undergo serial prostate biopsy.
- Overall life expectancy less than 2 years
- Advanced prostate cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Los Angeles
Los Angeles, California, 90095, United States
Biospecimen
Serum, plasma, buffy coat, prostate tissue cores and urine.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard S Marks, M.D.
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
July 4, 2009
Primary Completion (Estimated)
July 5, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share