- Email: [email protected]
999 SELECTIVE DETECTION OF HISTOLOGICALLY AGGRESSIVE PROSTATE CANCER: VALIDATION BY PCPT COHORT DATA OF AN EDRN PREDICTIVE MODEL TO REDUCE UNNECESSARY PROSTATE BIOPSIES
e402
THE JOURNAL OF UROLOGY姞
the celecoxib and placebo arms. The median serum PSA at baseline was 6.0ng/ml and 6.2ng/ml for the celecoxib and placebo groups, respectively, and did not significantly change over the course of the trial. There was no difference in post-operative opiate usage between the two arms. CONCLUSIONS: Administration of a selective COX-2 inhibitor had no significant effects on cancer cell apoptosis, prostaglandins or androgen receptor levels in cancerous or benign prostate tissues. These findings coupled with concerns over drug safety should serve to limit interest in the development of this drug class in prostate cancer chemoprevention. Source of Funding: Supported by VA Merit Review, Dept of Defense (PC040506) and Pfizer 635-ONC-0509-010
997 RISK FOR RECURRENT PROSTATE CANCER INCREASES WITH CHOLESTEROL ON A CONTINUUM IN MEN WITH ABNORMAL CHOLESTEROL LEVELS - AN UPDATE FROM THE SEACH DATABASE Lionel L. Ban˜ez*, Leah Gerber, Durham, NC; William J. Aronson, Los Angeles, CA; Martha K. Terris, Augusta, GA; Joseph C. Presti Jr., Palo Alto, CA; Christopher J. Kane, San Diego, CA; Christopher L. Amling, Portland, OR; Stephen J. Freedland, Durham, NC INTRODUCTION AND OBJECTIVES: There is mounting interest in elucidating the link between lipid dysregulation and prostate cancer (CaP) progression. Published data suggest that derangement of cholesterol (CHOL) levels may adversely impact recurrent CaP risk as well as long term outcomes. However, the relationship between serum CHOL and post-treatment biochemical recurrence (BCR) is not wellestablished. In 2008, we presented preliminary findings on 471 men from the Shared Equal Access Regional Cancer Hospital (SEARCH) database which suggested that elevated CHOL is associated with increased BCR risk. Herein, we present an updated analysis on a larger multi-racial cohort of veterans who underwent radical prostatectomy (RP). METHODS: We identified 921 men from the (SEARCH) database who underwent RP from 1992 to 2007 and had available total CHOL, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides (TRIG) levels and known statin use status prior to RP. CHOL, LDL, HDL and TRIG were treated as continuous variables. We used proportional hazards regression to assess associations of cholesterol, LDL and HDL levels with BCR independent of age, race, PSA, year of surgery, body mass index, surgical center, biopsy Gleason sum, clinical stage, pathological Gleason sum, surgical margin status, extracapsular extension, seminal vesicle invasion, lymph node involvement, prostate specimen weight and statin drug-use. Risk for BCR was assessed with lipid levels overall and as subsets wherein cases had deranged values specific to each lipid type (CHOL ⬎200; LDL ⬎100; HDL ⬍40; TRIG ⬎100 mg/dl). RESULTS: For all-comers, pre-operative CHOL, LDL, HDL and TRIG levels, taken as continuous terms, were not associated with BCR risk (all pⱖ0.09) even after controlling for potential confounders, including intake of cholesterol-lowering drugs. However, when the analysis was restricted to men with CHOL ⬎200 mg/dl, serum CHOL levels were significantly associated with increased BCR risk (log-transformed: HR 4.33; 95% CI 1.20 –15.60; p⫽0.025). LDL, HDL and TRIG were not associated with BCR even when respective levels are deranged. CONCLUSIONS: In this updated analysis wherein we nearly doubled our study sample size, CHOL levels increase the likelihood of post-RP BCR but only when total CHOL is abnormal. This finding suggests that the negative impact of lipid dysregulation becomes evident only after a threshold level is reached. If confirmed, these findings support investigating lipid control as a viable method of preventing CaP progression. Source of Funding: Dept of Veterans Affairs, Dept of Defense, NIH, and the AUA Foundation/Astellas Rising Star in Urology Award
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
998 11C-CHOLINE-PET/CT VERSUS TRANSRECTAL ULTRASOUNDGUIDED PROSTATE BIOPSY TO DIAGNOSE LOCALLY RECURRENT PROSTATE CANCER FOLLOWING RADIATION THERAPY Axel Heidenreich*, Robin Epplen, Bernhard Brehmer, David Thu¨er, Thomas van Erps, David Pfister, Aachen, Germany INTRODUCTION AND OBJECTIVES: Radical salvage prostatectomy (SRP) represents one local secondary treatment option with curative intent in patients failing radiation therapy (RT) for localized prostate cancer (PCA). 11C-PET/CT represents an innovative imaging study to detect systemic spread of prostate cancer. However, there is only limited experience with regard to the sensitivity of C-PET/CT to detect locally recurrent PCA following radiation therapy. The purpose of our study was to analyse the sensitivity of C-PET/CT to diagnose PCA and extra- and intraprostatic extension. METHODS: 45 patients with the suspicion of locally recurrent PCA underwent 12-core transrectal ultrasound-guided biopsy of the prostate, C-PET/CT, bonne scan and radical salvage prostatectomy. Findings of the imaging studies were correlated with the pathohistological findings of the prostate biopsy and the radical prostatectomy specimen. All prostatectomy specimens were proceeded according to the Stanford protocol and the number and location of intraprostatic cancer foci ⬎ 5mm were correlated with the PE/CT findings. RESULTS: The mean preoperative serum PSA was 7.8 (2–24) ng/ml; the mean biopsy Gleason Score was 5.6 (4 –9). Prostate biopsy was positive in 37/45 (82.2%) patients whereas 8/45 (17.8%) had a negative biopsy despite positive PET/CT findings. PET/CT was positive with 1–3 intraprostatic cancer foci in 45/45 patients. Radical prostatectomy specimens identified locally recurrent PCA in 44/45 (97.8%). One patient turned out to have pT0pN0 disease despite increasing PSA. PET/CT identified 1, 2, and ⬎ 2 intraprostatic cancer foci of significant volume in 23 (51.1%), 13 (28.9%) and 9 (20%) patients, resp.. Sensitivity to detect intraprostatic, histologically proven PCA foci is 95.6% which is significantly superior to the biopsy results. There was a high correlation between the PET/CT results and the final histology of the radical prostatectomy specimens. CONCLUSIONS: Choline PET/CT is an innovative imaging to identify patients with locally recurrent PCA following radiation therapy. PET/CT is superior to prostate biopsy and we recommend a PET/CT in patients who are candidates for radical salvage prostatectomy. Source of Funding: None
999 SELECTIVE DETECTION OF HISTOLOGICALLY AGGRESSIVE PROSTATE CANCER: VALIDATION BY PCPT COHORT DATA OF AN EDRN PREDICTIVE MODEL TO REDUCE UNNECESSARY PROSTATE BIOPSIES Stephen Williams*, Simpa Salami, Meredith Regan, Boston, MA; Donna Ankerst, San Antonio, TX; John Wei, Ann Arbor, MI; Mark Rubin, New York, NY; Ian Thompson, San Antonio, TX; Martin Sanda, Boston, MA INTRODUCTION AND OBJECTIVES: Modest survival benefits of prostate cancer screening based on PSA alone, coupled with evidence of concurrent over-treatment of indolent prostate cancer, suggest a need to better identify candidates for prostate biopsy by discerning risk of aggressive versus indolent cancer before biopsy. METHODS: A multi-center National Cancer Institute Early Detection Research Network (EDRN) cohort was analyzed to develop a logistic regression model using routinely available clinical parameters to predict histologically significant cancers. In the model, age, body mass index, family history, abnormal digital rectal exam (DRE) and PSA density (PSAD) were independently associated with significant cancer (all p⬍0.001). Data from the placebo arm (n⫽3833) of the Prostate Cancer Prevention Trial (PCPT) were evaluated for external calibration / validation of the predictive model.
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
RESULTS: In the model development cohort, the multivariable model improved prediction of histopathologically aggressive cancer on biopsy over PSA alone (AUC ⫽ 0.81 vs. 0.71, p ⬍ 0.01). A subsequent EDRN subject set showed that 25% of men undergoing biopsy had ⬍10% probability of having aggressive prostate cancer. Interrogation of the control arm of PCPT showed 3833 subjects with available information regarding the clinical parameters comprising the predictive model; from among these, 333 had aggressive cancer on biopsy, 324 had indolent cancer, and the remainder had no cancer (Table 1). The EDRN model accurately identified PCPT participants at low (⬍10%) risk of prostate cancer (AUC⫽0.78; 95% CI .75–.80), for whom biopsy could be averted (Table 2). CONCLUSIONS: A predictive model incorporating age, family history, obesity, PSAD and DRE has elucidated criteria for low risk of prostate cancer (combination of normal DRE and no family history of prostate cancer and PSAD ⬍0.1 and BMI ⬍ 25 kg/m2) whereby one-quarter of prostate biopsies can be averted while retaining high sensitivity for detecting significant prostate cancer.
THE JOURNAL OF UROLOGY姞
e403
RESULTS: A fifth of the sample (19.7%) reported clinically elevated levels of depressive symptoms at baseline. Using multiple regression, depressive symptoms at baseline and treatment modality significantly predicted sexual and urinary dysfunction, related bother, and activity limitation due to urinary dysfunction at 6-month controlling for age, PSA level, Gleason score, and relevant baseline indicators of sexual and urinary dysfunction, related bother and activity limitation (ps ⬍ .05). CONCLUSIONS: Pre-treatment depressive symptoms and treatment modality predict QOL after CaP treatment. Health care providers should be sensitive to the display of depressive symptoms before CaP treatment and consider preventative interventions including preparing patients for the changes in disease-specific QOL and related bother following prostate cancer treatment. Source of Funding: CA6136-04,CA06927, DAMD 17-1-1-006
1001 DECISIONAL CONFLICT VARIES BY INSTITUTION FOR MEN MAKING TREATMENT DECISIONS FOR LOCALIZED PROSTATE CANCER Donna Berry*, Fangxin Hong, Barbara Halpenny, Boston, MA; Seth Wolpin, William Lober, Kenneth Russell, William Ellis, Seattle, WA; B. Joyce Davison, Saskatoon, Canada; Andrea Barsevick, Philadephia, PA; Claire Yang, Daniel Lin, Seattle, WA; Gerald Bennett, Augusta, GA
Source of Funding: NCI-EDRN U01 CA113913
1000 CLINICAL DEPRESSION AT TIME OF PROSTATE CANCER DIAGNOSIS PREDICTS SEXUAL AND URINARY DYSFUNCTION 6 MONTHS POST TREATMENT FOR LOCALIZED PROSTATE CANCER Michael Diefenbach*, Nihal Mohamed, Simon Hall, New York, NY INTRODUCTION AND OBJECTIVES: The present study uses a prospective design to examine the influence of depressive symptoms before prostate cancer treatment on post-treatment disease-specific QOL (i.e., urinary and sexual functioning) controlling for treatment modality and relevant demographic and clinical covariates. METHODS: A case series of patients diagnosed with localized CaP (T1-2N0M0) at a comprehensive cancer center were assessed. 869 patients completed questionnaires at diagnosis (baseline) and six months following treatment. Patients were on average 66 years old (SD ⫽ 8.10, range 39 –95 years), Caucasians (89.1%), married (80.5%), had college education or post-graduate education (48.9%), or were retired at the time of baseline assessment (57.6%). Patients were treated with surgery (17%), brachytherapy (27%), or external beam radiation (EBRT; 55%). Depressive symptoms and disease specific QOL were assessed with established measures (i.e., Center for Epidemiologic Studies Depression Scale (CES-D); sexual adjustment questionnaire (SAQ); and the American Urological Association symptom index).
INTRODUCTION AND OBJECTIVES: Diagnosed with localized prostate cancer (LPC), men often struggle to make “the best” treatment decision. The Personal Patient Profile-Prostate (P3P), a customized Internet-based decision support system for men with LPC, has been shown to significantly reduce decisional conflict in a multi-site randomized trial. In this diverse sample of men with LPC, we explored differences in the decisional conflict (DC) outcome between clinical study sites. METHODS: Men with newly diagnosed LPC in Seattle, Philadelphia, San Antonio and Augusta (3 Veterans Administration urology sites, 1 private radiation oncology site, 1 cancer center radiation oncology site, and 1 cancer center multidisciplinary clinic site) were invited to enter the P3P program prior to their consultation visit with a cancer specialist. All participants answered questionnaires at baseline, 1 and 6 months, including the DC Scale (⫹3 subscales). Men randomized to the intervention group received the P3P text and video coaching, customized to race and age. Generalized Estimating Equation (GEE) was used to model the DC outcomes at 1 and 6 months, adjusting for baseline DC scores and potential predictive demographic/ clinical factors. Separate models were used for each subscale and the total score. Chi-square and one-way ANOVA were used for comparing baseline demographic factors among study sites. RESULTS: A total of 494 eligible men were enrolled and randomized with 15% minority participation. Differences between study sites were found for decisional conflict in all three subscales (decisional uncertainty, p⫽0.0082; factors contributing to uncertainty, p⫽ 0.0015, effective decision-making, p⫽0.0026) and total scores (p⫽0.0074). Though baseline demographics (education, income, race, weeks since diagnosis, home Internet access) were significantly different by site (p⬍0.0001), the difference in DC among sites remained after adjusting for these demographics and baseline DC scores in the GEE model. Participants at the Augusta Veterans Administration urology clinic reported highest decisional conflict, while patients at Seattle Prostate Institute reported lowest decisional conflict. CONCLUSIONS: Men with LPC receiving care at institutional settings of various types are likely to have different levels of decision conflict and this is not fully explained by participant demographics. Differences between sites on unknown variables may explain the finding. Future analyses and further research are indicated to uncover the origin of this difference. Source of Funding: National Institutes of Health
THE JOURNAL OF UROLOGY姞
the celecoxib and placebo arms. The median serum PSA at baseline was 6.0ng/ml and 6.2ng/ml for the celecoxib and placebo groups, respectively, and did not significantly change over the course of the trial. There was no difference in post-operative opiate usage between the two arms. CONCLUSIONS: Administration of a selective COX-2 inhibitor had no significant effects on cancer cell apoptosis, prostaglandins or androgen receptor levels in cancerous or benign prostate tissues. These findings coupled with concerns over drug safety should serve to limit interest in the development of this drug class in prostate cancer chemoprevention. Source of Funding: Supported by VA Merit Review, Dept of Defense (PC040506) and Pfizer 635-ONC-0509-010
997 RISK FOR RECURRENT PROSTATE CANCER INCREASES WITH CHOLESTEROL ON A CONTINUUM IN MEN WITH ABNORMAL CHOLESTEROL LEVELS - AN UPDATE FROM THE SEACH DATABASE Lionel L. Ban˜ez*, Leah Gerber, Durham, NC; William J. Aronson, Los Angeles, CA; Martha K. Terris, Augusta, GA; Joseph C. Presti Jr., Palo Alto, CA; Christopher J. Kane, San Diego, CA; Christopher L. Amling, Portland, OR; Stephen J. Freedland, Durham, NC INTRODUCTION AND OBJECTIVES: There is mounting interest in elucidating the link between lipid dysregulation and prostate cancer (CaP) progression. Published data suggest that derangement of cholesterol (CHOL) levels may adversely impact recurrent CaP risk as well as long term outcomes. However, the relationship between serum CHOL and post-treatment biochemical recurrence (BCR) is not wellestablished. In 2008, we presented preliminary findings on 471 men from the Shared Equal Access Regional Cancer Hospital (SEARCH) database which suggested that elevated CHOL is associated with increased BCR risk. Herein, we present an updated analysis on a larger multi-racial cohort of veterans who underwent radical prostatectomy (RP). METHODS: We identified 921 men from the (SEARCH) database who underwent RP from 1992 to 2007 and had available total CHOL, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides (TRIG) levels and known statin use status prior to RP. CHOL, LDL, HDL and TRIG were treated as continuous variables. We used proportional hazards regression to assess associations of cholesterol, LDL and HDL levels with BCR independent of age, race, PSA, year of surgery, body mass index, surgical center, biopsy Gleason sum, clinical stage, pathological Gleason sum, surgical margin status, extracapsular extension, seminal vesicle invasion, lymph node involvement, prostate specimen weight and statin drug-use. Risk for BCR was assessed with lipid levels overall and as subsets wherein cases had deranged values specific to each lipid type (CHOL ⬎200; LDL ⬎100; HDL ⬍40; TRIG ⬎100 mg/dl). RESULTS: For all-comers, pre-operative CHOL, LDL, HDL and TRIG levels, taken as continuous terms, were not associated with BCR risk (all pⱖ0.09) even after controlling for potential confounders, including intake of cholesterol-lowering drugs. However, when the analysis was restricted to men with CHOL ⬎200 mg/dl, serum CHOL levels were significantly associated with increased BCR risk (log-transformed: HR 4.33; 95% CI 1.20 –15.60; p⫽0.025). LDL, HDL and TRIG were not associated with BCR even when respective levels are deranged. CONCLUSIONS: In this updated analysis wherein we nearly doubled our study sample size, CHOL levels increase the likelihood of post-RP BCR but only when total CHOL is abnormal. This finding suggests that the negative impact of lipid dysregulation becomes evident only after a threshold level is reached. If confirmed, these findings support investigating lipid control as a viable method of preventing CaP progression. Source of Funding: Dept of Veterans Affairs, Dept of Defense, NIH, and the AUA Foundation/Astellas Rising Star in Urology Award
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
998 11C-CHOLINE-PET/CT VERSUS TRANSRECTAL ULTRASOUNDGUIDED PROSTATE BIOPSY TO DIAGNOSE LOCALLY RECURRENT PROSTATE CANCER FOLLOWING RADIATION THERAPY Axel Heidenreich*, Robin Epplen, Bernhard Brehmer, David Thu¨er, Thomas van Erps, David Pfister, Aachen, Germany INTRODUCTION AND OBJECTIVES: Radical salvage prostatectomy (SRP) represents one local secondary treatment option with curative intent in patients failing radiation therapy (RT) for localized prostate cancer (PCA). 11C-PET/CT represents an innovative imaging study to detect systemic spread of prostate cancer. However, there is only limited experience with regard to the sensitivity of C-PET/CT to detect locally recurrent PCA following radiation therapy. The purpose of our study was to analyse the sensitivity of C-PET/CT to diagnose PCA and extra- and intraprostatic extension. METHODS: 45 patients with the suspicion of locally recurrent PCA underwent 12-core transrectal ultrasound-guided biopsy of the prostate, C-PET/CT, bonne scan and radical salvage prostatectomy. Findings of the imaging studies were correlated with the pathohistological findings of the prostate biopsy and the radical prostatectomy specimen. All prostatectomy specimens were proceeded according to the Stanford protocol and the number and location of intraprostatic cancer foci ⬎ 5mm were correlated with the PE/CT findings. RESULTS: The mean preoperative serum PSA was 7.8 (2–24) ng/ml; the mean biopsy Gleason Score was 5.6 (4 –9). Prostate biopsy was positive in 37/45 (82.2%) patients whereas 8/45 (17.8%) had a negative biopsy despite positive PET/CT findings. PET/CT was positive with 1–3 intraprostatic cancer foci in 45/45 patients. Radical prostatectomy specimens identified locally recurrent PCA in 44/45 (97.8%). One patient turned out to have pT0pN0 disease despite increasing PSA. PET/CT identified 1, 2, and ⬎ 2 intraprostatic cancer foci of significant volume in 23 (51.1%), 13 (28.9%) and 9 (20%) patients, resp.. Sensitivity to detect intraprostatic, histologically proven PCA foci is 95.6% which is significantly superior to the biopsy results. There was a high correlation between the PET/CT results and the final histology of the radical prostatectomy specimens. CONCLUSIONS: Choline PET/CT is an innovative imaging to identify patients with locally recurrent PCA following radiation therapy. PET/CT is superior to prostate biopsy and we recommend a PET/CT in patients who are candidates for radical salvage prostatectomy. Source of Funding: None
999 SELECTIVE DETECTION OF HISTOLOGICALLY AGGRESSIVE PROSTATE CANCER: VALIDATION BY PCPT COHORT DATA OF AN EDRN PREDICTIVE MODEL TO REDUCE UNNECESSARY PROSTATE BIOPSIES Stephen Williams*, Simpa Salami, Meredith Regan, Boston, MA; Donna Ankerst, San Antonio, TX; John Wei, Ann Arbor, MI; Mark Rubin, New York, NY; Ian Thompson, San Antonio, TX; Martin Sanda, Boston, MA INTRODUCTION AND OBJECTIVES: Modest survival benefits of prostate cancer screening based on PSA alone, coupled with evidence of concurrent over-treatment of indolent prostate cancer, suggest a need to better identify candidates for prostate biopsy by discerning risk of aggressive versus indolent cancer before biopsy. METHODS: A multi-center National Cancer Institute Early Detection Research Network (EDRN) cohort was analyzed to develop a logistic regression model using routinely available clinical parameters to predict histologically significant cancers. In the model, age, body mass index, family history, abnormal digital rectal exam (DRE) and PSA density (PSAD) were independently associated with significant cancer (all p⬍0.001). Data from the placebo arm (n⫽3833) of the Prostate Cancer Prevention Trial (PCPT) were evaluated for external calibration / validation of the predictive model.
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
RESULTS: In the model development cohort, the multivariable model improved prediction of histopathologically aggressive cancer on biopsy over PSA alone (AUC ⫽ 0.81 vs. 0.71, p ⬍ 0.01). A subsequent EDRN subject set showed that 25% of men undergoing biopsy had ⬍10% probability of having aggressive prostate cancer. Interrogation of the control arm of PCPT showed 3833 subjects with available information regarding the clinical parameters comprising the predictive model; from among these, 333 had aggressive cancer on biopsy, 324 had indolent cancer, and the remainder had no cancer (Table 1). The EDRN model accurately identified PCPT participants at low (⬍10%) risk of prostate cancer (AUC⫽0.78; 95% CI .75–.80), for whom biopsy could be averted (Table 2). CONCLUSIONS: A predictive model incorporating age, family history, obesity, PSAD and DRE has elucidated criteria for low risk of prostate cancer (combination of normal DRE and no family history of prostate cancer and PSAD ⬍0.1 and BMI ⬍ 25 kg/m2) whereby one-quarter of prostate biopsies can be averted while retaining high sensitivity for detecting significant prostate cancer.
THE JOURNAL OF UROLOGY姞
e403
RESULTS: A fifth of the sample (19.7%) reported clinically elevated levels of depressive symptoms at baseline. Using multiple regression, depressive symptoms at baseline and treatment modality significantly predicted sexual and urinary dysfunction, related bother, and activity limitation due to urinary dysfunction at 6-month controlling for age, PSA level, Gleason score, and relevant baseline indicators of sexual and urinary dysfunction, related bother and activity limitation (ps ⬍ .05). CONCLUSIONS: Pre-treatment depressive symptoms and treatment modality predict QOL after CaP treatment. Health care providers should be sensitive to the display of depressive symptoms before CaP treatment and consider preventative interventions including preparing patients for the changes in disease-specific QOL and related bother following prostate cancer treatment. Source of Funding: CA6136-04,CA06927, DAMD 17-1-1-006
1001 DECISIONAL CONFLICT VARIES BY INSTITUTION FOR MEN MAKING TREATMENT DECISIONS FOR LOCALIZED PROSTATE CANCER Donna Berry*, Fangxin Hong, Barbara Halpenny, Boston, MA; Seth Wolpin, William Lober, Kenneth Russell, William Ellis, Seattle, WA; B. Joyce Davison, Saskatoon, Canada; Andrea Barsevick, Philadephia, PA; Claire Yang, Daniel Lin, Seattle, WA; Gerald Bennett, Augusta, GA
Source of Funding: NCI-EDRN U01 CA113913
1000 CLINICAL DEPRESSION AT TIME OF PROSTATE CANCER DIAGNOSIS PREDICTS SEXUAL AND URINARY DYSFUNCTION 6 MONTHS POST TREATMENT FOR LOCALIZED PROSTATE CANCER Michael Diefenbach*, Nihal Mohamed, Simon Hall, New York, NY INTRODUCTION AND OBJECTIVES: The present study uses a prospective design to examine the influence of depressive symptoms before prostate cancer treatment on post-treatment disease-specific QOL (i.e., urinary and sexual functioning) controlling for treatment modality and relevant demographic and clinical covariates. METHODS: A case series of patients diagnosed with localized CaP (T1-2N0M0) at a comprehensive cancer center were assessed. 869 patients completed questionnaires at diagnosis (baseline) and six months following treatment. Patients were on average 66 years old (SD ⫽ 8.10, range 39 –95 years), Caucasians (89.1%), married (80.5%), had college education or post-graduate education (48.9%), or were retired at the time of baseline assessment (57.6%). Patients were treated with surgery (17%), brachytherapy (27%), or external beam radiation (EBRT; 55%). Depressive symptoms and disease specific QOL were assessed with established measures (i.e., Center for Epidemiologic Studies Depression Scale (CES-D); sexual adjustment questionnaire (SAQ); and the American Urological Association symptom index).
INTRODUCTION AND OBJECTIVES: Diagnosed with localized prostate cancer (LPC), men often struggle to make “the best” treatment decision. The Personal Patient Profile-Prostate (P3P), a customized Internet-based decision support system for men with LPC, has been shown to significantly reduce decisional conflict in a multi-site randomized trial. In this diverse sample of men with LPC, we explored differences in the decisional conflict (DC) outcome between clinical study sites. METHODS: Men with newly diagnosed LPC in Seattle, Philadelphia, San Antonio and Augusta (3 Veterans Administration urology sites, 1 private radiation oncology site, 1 cancer center radiation oncology site, and 1 cancer center multidisciplinary clinic site) were invited to enter the P3P program prior to their consultation visit with a cancer specialist. All participants answered questionnaires at baseline, 1 and 6 months, including the DC Scale (⫹3 subscales). Men randomized to the intervention group received the P3P text and video coaching, customized to race and age. Generalized Estimating Equation (GEE) was used to model the DC outcomes at 1 and 6 months, adjusting for baseline DC scores and potential predictive demographic/ clinical factors. Separate models were used for each subscale and the total score. Chi-square and one-way ANOVA were used for comparing baseline demographic factors among study sites. RESULTS: A total of 494 eligible men were enrolled and randomized with 15% minority participation. Differences between study sites were found for decisional conflict in all three subscales (decisional uncertainty, p⫽0.0082; factors contributing to uncertainty, p⫽ 0.0015, effective decision-making, p⫽0.0026) and total scores (p⫽0.0074). Though baseline demographics (education, income, race, weeks since diagnosis, home Internet access) were significantly different by site (p⬍0.0001), the difference in DC among sites remained after adjusting for these demographics and baseline DC scores in the GEE model. Participants at the Augusta Veterans Administration urology clinic reported highest decisional conflict, while patients at Seattle Prostate Institute reported lowest decisional conflict. CONCLUSIONS: Men with LPC receiving care at institutional settings of various types are likely to have different levels of decision conflict and this is not fully explained by participant demographics. Differences between sites on unknown variables may explain the finding. Future analyses and further research are indicated to uncover the origin of this difference. Source of Funding: National Institutes of Health