Active Surveillance for Cancer of the Prostate (ASCaP)

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Active surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Unwillingness or inability to undergo serial prostate biopsy. Overall life expectancy less than 2 years Advanced prostate cancer

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br>Men with previously untreated, early stage prostate cancer. | Other: Active surveillance<br>* Serial, long term data collection and active surveillance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Low risk, Gleason 6, Active surveillance