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Study Summary
No. 2005-0619:.......Prostate......Jeri Kim......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:		2005-0619
Study Title:Active Surveillance in Prostate Cancer: A Prospective Cohort Study
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Physician New Patient Referral
Name:Jeri KimPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:N/A
Phase of Study:N/AReturn
Visit:		Every 6 months during surveillance.
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to find out if men who have a type
of prostate cancer that has been classified as "low risk" can safely not be
treated for the disease. Doctors want to know if patients with "low risk"
cancer can avoid or postpone therapy and the related side effects and still
live as long as patients who immediately receive therapy.
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Study Objectives / Outcomes
Primary objective:
To estimate the 5-year disease progression rate of patients with low-risk prostate cancer who choose to
undergo active surveillance.

Secondary objectives:
1. To examine psychosocial adjustment and quality of life in patients on active surveillance.
2. To estimate the 10-year disease progression rate of patients with low-risk prostate cancer who choose to undergo active surveillance.

Tertiary objectives:
1. To determine the feasibility of routinely applying a surveillance strategy consisting of prostate-specific antigen (PSA) level evaluations, digital rectal examination (DRE), transrectal ultrasound, a multisite extended biopsies scheduled according to findings at the biopsy performed at the end of year 1.
2. To assess the effect of dietary intake and body mass index on clinicopathologic correlates of disease progression.
3. To archive tissue and blood prospectively to identify and characterize biomarker correlates of disease progression.
4. To estimate the overall survival rate of men undergoing active surveillance.
5. To estimate the 10-year prostate cancer specific survival rate of men undergoing active surveillance.
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Study Status Information
Study Activation / Registration Date:02/13/2006
IRB Review and Approval Date:02/13/2006
Study Type:Observational
Recruitment Status:Open
Projected Accrual:1000
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients will have histologic proof of adenocarcinoma of the prostate within six months of study entry.

2) Patients must agree to have repeat extended 11-core multisite biopsy (sextant locations, midline, and 2 cores each from the left and right anterior horn) of the prostate at study entry. A baseline prostate biopsy is not indicated if a repeat biopsy following the extended biopsy scheme (at least 10 biopsy cores) was performed at The University of Texas M. D. Anderson Cancer Center (MDACC) within 6 months of study entry.

3) Patients who have clinically localized cancer defined by pathologic and PSA criteria to be very low-risk/low-risk, patients with clinically localized cancer [not low-risk] who have refused early intervention or chosen active surveillance as a management option, and patients with clinically localized cancer who are precluded from local therapy because of comorbidities.

4) Patients must agree to comply with the surveillance schedule.

5) Non-English speaking patients may participate in the study, but they will not be required to complete the surveys.

6) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Exclusion Criteria:1) Active noncutaneous malignancy at any site.

2) Prior radiation therapy for treatment of the primary tumor.

3) Planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy while on protocol.
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Links
Registration Number: NCT00490763
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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