Active Surveillance for Cancer of the Prostate (ASCaP)
Status
RECRUITING
Phase
Age
30 - 85 Years
Enrollments
462Conditions
Prostate CancerSummary
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
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Leonard S Marks, M.D.
Principal Investigator
- Leonard S Marks, M.D.
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 Plan
no treatment
Men with previously untreated, early stage prostate cancer.
OTHER:
Active surveillanceDescription:
Serial, long term data collection and active surveillance
Outcome Measures
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.
Secondary Outcome Measures
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
Timeline
Last Updated
May 8, 2024Start Date
July 30, 2009Today
January 16, 2025Completion Date ( Estimated )
December 1, 2028
Sponsors of this trial
Lead Sponsor
Jonsson Comprehensive Cancer Center
RECRUITING 
21 - 64 Years