Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Can screening among the general adult male population for elevated PCA3 (also known as DD3) gene expression, to identify those at risk for prostate cancer who may be candidates for prostate biopsy, reduce morbidity and mortality?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Use of commercially available PCA3 expression assays for prostate cancer screening tests vs. screening by PSA testing, other screening methods, or no screening.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Applies to general population of adult men.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Older adult male population.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Interested in improved health related outcomes resulting from improved/earlier detection of prostate cancer that may result from testing.

Describe any health-related risks, side effects, or harms that you are concerned about.

May lead to unnecessary follow-up for men who are asymptomatic or have slowly progressing prostate cancer. Not clear if outcomes will be improved.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cancer

AHRQ Priority Populations

• Minority groups

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Prostate cancer is among the most frequently diagnosed and deadliest cancers among men in the U.S. Tests are currently available to detect PCA3 mRNA expression.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

EGAPP Working Group plans to develop evidence-based guidelines based on the results of this systematic review.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

It is unclear whether this PCA3 screening will allow earlier and/or better detection than existing screening methods, and whether earlier detection through this type of screening would have benefit or not.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

EGAPP Working Group plans to develop evidence-based guidelines based on the results of this systematic review.

Describe the timeframe in which an answer to your question is needed.

Ideally within 1 year.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

EGAPP Working Group plans to develop evidence-based guidelines based on the results of this systematic review.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program