The Prostate Risk Assessment Program

Given the need to identify appropriate target populations for prevention and screening studies, many institutions have begun to establish registries for patients at risk. Here we review the findings from one of the first institutional programs designed to collect such information. The Fox Chase Cancer Center (FCCC) Prostate Cancer Risk Registry (PCRR) and Prostate Cancer Risk Assessment Program (PRAP) were founded in 1996. The FCCC is an NCI-designated Comprehensive Cancer Center committed to the support of cancer prevention and early detection. The PRAP has been developed building on the successful history of the FCCC Family Risk Assessment Programs for breast and ovarian cancers. PRAP is a multidisciplinary effort that includes clinicians across multiple disciplines, basic and behavioral scientists, genetic counselors, health educators, biostatisticians and others. This team has developed a program for prostate cancer risk analysis, risk education, early detection, and testing of risk reduction and cancer prevention strategies.

Objectives and aims

The primary objectives of the PCRR and PRAP are to establish a registry and screening clinic for families at high risk for prostate cancer, to further our understanding of the complex mechanisms of prostate carcinogenesis, and to provide prevention, early detection and psychosocial interventions to unaffected individuals at high risk. Secondary objectives include the study of prostate cancer genetics through the creation of a high-risk specimen bank, the development and testing of tools for intervention and prevention strategies, and the evaluation of behavioral interventions to assist in educating, processing and coping with risk-related information.

PRAP eligibility

PRAP eligibility criteria for at-risk populations include African Americans, men with at least one first-degree relative or two or more second-degree relatives with prostate cancer on the same

Men/families at high risk for prostate cancer

Risk registry

• Identification of those eligible

• Recruitment

• Informed consent

• Database development

- data files

- data entry

- data storage

- data retrieval

- confidentiality

Screening

• Telephone registration

• Consultation

- Education

Prostate anatomy Prostate cancer Risk factors Sporadic, familial, hereditary Possible risk modifiers DRE/PSA information

- Assessment Sociodemographics Family history Health history

Diet history Quality of life Risk perceptors Risk behaviors Coping skills -Clinical examination DRE

PSA (free/total) Genetic test (when available)

- Pedigree review

- Results of genetic test

(when available)

- Genetic counseling

- Dietary results and recommendations

- Potential risk modifiers

- F/U recommendations

• Annual follow-up

Genetic research

• Linkage analysis

• Risk modeling

• Breast-prostate phenotype

• Genetic testing of oncogenes and tumor suppressor genes

• Genetic markers

• Protocols for assessments and counseling

Behavioral research

• Risk comprehension

• Risk adjustment

• Risk reduction

• Risk education tools

Early detection, risk reduction, cancer prevention strategies

Outcomes research

• Cancers detected - stage, grade

• Life years saved

• Preferences/utilities

• Cost effectiveness

• Patient satisfaction

Fig. 10.3. The Fox Chase Cancer Center model for a unified multidisciplinary Prostate Risk Assessment Program (PRAP).49

side of the family, or men who have tested positive for the BRCA1 gene mutation. PRAP eligibility is limited to men aged 35-69 years of age. The lower bound age was based on reports of early age of onset for at-risk men and the upper bound age was based on the PRAP goal of targeting men at-risk prior to the mean age of onset of prostate cancer for the general population.48 The PCRR includes affected family members of PRAP participants.

The logistics of the PRAP and PCRR, including recruitment, registration, the screening appointment, feedback and follow-up are outlined in Fig. 10.3 and are described in detail elsewhere.49 The program includes an extensive assessment of family history, pertinent medical history, dietary habits, preventive health care behaviors, risk perceptions, psychological status and quality of life. An educational session and interview with a genetic counselor is mandatory prior to screening and informed consent. Most importantly, the health educator and genetic counselor work to answer questions and keep concerns in perspective. Following education, the participant has blood drawn for PSA (total and % free) and research purposes after which the physician takes a targeted health history and performs the digital rectal examination (DRE). An appointment for the feedback of results is made for approximately 4 weeks postscreening. In the interim, a pedigree is generated and reviewed, the PSA results are obtained, and a computer printout of nutritional intake is generated and analyzed. Men with abnormal results, particularly an elevated total or low percentage % PSA, are contacted by the physician for consultation and appropriate referrals for diagnostic follow-up are made.

Participants with a normal PSA or DRE return to PRAP for their feedback visit where they meet with the genetic counselor to review their pedigree and receive the physician's follow-up instructions, which generally consist of annual or, when appropriate, semiannual screening. Other familial or hereditary illnesses discovered on pedigree review are discussed along with appropriate follow-up and referral.

Implications of the findings for the participant and family members are discussed in addition to dietary recommendations and potential preventive health behaviors, including prevention clinical trials when appropriate.

Preliminary results

PRAP/PCRR accrual

Since its inception in October 1996 through August 2001, PRAP accrual has accrued nearly 400 men at increased risk for

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