Prostate Cancer
Conditions
Keywords
Prostate Cancer, Low risk, Gleason 6, Active surveillance
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.
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
Interventions
OTHERActive surveillance
Serial, long term data collection and active surveillance
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTMalu Macairan
CONTACTLeonard S Marks, M.D.
PRINCIPAL_INVESTIGATORLeonard S Marks, M.D.
University of California, Los Angeles
Outcome results
None listed