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March 2008

Active Surveillance Viable Option for Prostate Cancer Management

Peter R. Carroll, M.D.
Chair of the UCSF Department of Urology
Ken and Donna Derr-Chevron Distinguished Professor
Director of Strategic Planning and Clinical Service
UCSF Helen Diller Family Comprehensive Cancer Center

Recent lowering of the prostate-specific antigen (PSA) threshold for recommending prostate biopsy has contributed to an increase in diagnosis and, in some cases, over-treatment of small, early-stage tumors. The dilemma is that active treatment for prostate cancer, no matter how well delivered, may be associated with potential decrement in quality of life in multiple domains, including urinary and sexual function.

About one in three men over age 50 have some evidence of prostate cancer, with the majority being limited in size and associated with moderate to slow growth rates. Recent evidence suggests that many of these men may not require immediate treatment and may l ive with insignificant prostate cancers with no detriment to their health or well being. As a result, the traditional concept of "watchful waiting" for prostate cancer has evolved to "active surveillance."

Rather than "waiting" until the cancer becomes symptomatic, active surveillance focuses on identifying the early signs of disease progression and treating the cancer before it spreads outside the prostate. Patients are selectively treated with every intention to provide a cure. Data suggests that well characterized, early stage tumors followed by experienced physicians and knowledgeable patients are not likely to progress rapidly and that deferring treatment is not likely to alter their natural course.

Selection Criteria

Critical to successful active surveillance is patient selection. The best candidates for active surveillance are those who have low-risk prostate cancer, defined as posing little immediate risk to the patient's health or well being. This can be estimated by assessing PSA levels, prostate needle biopsy results and findings on prostate gland ultrasound.

In addition, a well-performed biopsy — incorporating enough sites (usually more than 12) to limit the risk of under-grading and under-staging — is an important component of the assessment. Initial PSA values at diagnosis should be low (under 10) and should have been relatively stable over the past few years.

Candidates also should have a prostate biopsy Gleason sum of 6 or less with no more than 1/3 of total needle samples (for example, 4 or less out of 12) positive for cancer, and no greater than 50 percent of any single needle biopsy of prostate involved with cancer. To limit the risk of under-staging or under-grading the tumor, another biopsy of the prostate gland prior to embarking on active surveillance is often recommended. This is especially important if the diagnostic biopsy consisted of 6 or fewer tissue cores.

Common clinical data used to define low-risk prostate cancer:

Gleason sum6 (no pattern 4 or 5)
PSA at diagnosis10 ng/ml or less and stable
Positive cores33 percent or less
Single core involvement50 percent or less
Repeat PSAStable
UltrasoundOrgan confined

Protocol

Over 500 men have chosen active surveillance for management of prostate cancer at the UCSF Prostate Cancer Center, one of the few select centers worldwide developing this approach. About one in five men on active surveillance have received treatment for their cancer at an average of two to three years after diagnosis. The most common reason for recommending treatment is a rise in Gleason score on subsequent prostate biopsy.

Other indications to undergo treatment include a rapidly rising PSA or visibly increased tumor size on prostate ultrasound. All of these findings may indicate progression of the patient's cancer that warrants active treatment.

Active Surveillance Protocol at UCSF

PSAEvery 3 to 4 months
Prostate ultrasoundEvery 6 to 9 months
Prostate biopsyAfter 1 year *

*If a patient's initial biopsy was performed outside of UCSF, an additional biopsy performed at UCSF may be recommended within a few months. Biopsies then may be performed every one to two years depending on other clinical findings.

For more information, contact the Physician Referral Service at UCSF Medical Center:

Phone (888) 689-UCSF or (888) 689-8273
Email referral.center@ucsfmedctr.org

Other Resources

Prostate Patient Education
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Prostate Cancer High-Risk Clinic