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1002 EXAMINING AN INTERACTIVE, MULTIMEDIA EDUCATION AND DECISION PROGRAM FOR EARLY-STAGE PROSTATE CANCER PATIENTS
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THE JOURNAL OF UROLOGY姞
1002 EXAMINING AN INTERACTIVE, MULTIMEDIA EDUCATION AND DECISION PROGRAM FOR EARLY-STAGE PROSTATE CANCER PATIENTS Michael Diefenbach*, Nihal Mohamed, Simon Hall, New York, NY INTRODUCTION AND OBJECTIVES: Treatment options for localized prostate cancer (CaP) are characterized by excellent 5-yr survival prospects, but varying implications for quality of life. Thus, there is a need for extensive patient education for treatment decision making. We developed an Internet-based multimedia CaP educational software (PIES) that provides patients with information about CaP and its treatment through an intuitive interface, using video, animation, and text. We used the metaphor of a virtual health center to present the information. The current study evaluates the efficacy of PIES in facilitating decision making. We hypothesize that PIES will reduce decisional conflict and increase confidence in the treatment decision compared to standard care. METHODS: Patients diagnosed with localized CaP who had not made a treatment decision were randomized into 3 groups: a) Standard care receiving NCI print materials (n ⫽ 24); b) PIES with information tailored to information seeking preference (n ⫽ 39); c) PIES without tailored information (n ⫽ 27). We administrated questionnaires before the intervention (t1), following the intervention (t2), and six weeks later (t3). Measurements include the Decisional Conflict Scale (i.e., uncertainty in choosing options, informed decision, value clarification, decisional support, O’Connor, 1995) and measures to assess confidence in the decision and emotional impact of the information (Diefenbach et al., 2002). RESULTS: Patients were on average 60 years (SD ⫽ 1.18), white and married. There were no differences in outcome variables between the tailored and non-tailored PIES groups, thus they were combined (n ⫽ 66). At t2 the combined PIES group, compared to standard care, reported a significant increase in confidence to make a treatment decision, indicated that their decision was more congruent with their values, and experienced the information as more reassuring and less distressing (all ps ⬍ .05). Comparisons between baseline and the six weeks follow-up assessment showed that these effects persisted as patients in the PIES group continued to be better informed about their options, displayed reduced decisional uncertainty, and were better informed about the benefits that mattered most to them, compared to the standard care group. CONCLUSIONS: Using PIES prior to making a treatment decision leads to reduced decisional conflict, increased confidence, and a value concordant decision. Source of Funding: DAMD W81 XWH-04-1-0179
1003 PROSTATE CRYOABLATION BEFORE AND AFTER SOLID ORGAN TRANSPLANTATION Philippa Cheetham*, Scott Stevenson, Zahid Saeed, Max Pitman, Elton Llukani, Aaron Katz, New York, NY INTRODUCTION AND OBJECTIVES: Prostate cancer (PCa) is being diagnosed with increasing frequency due to routine PSA screening. To date, reported experiences with transplantation in men with a history of prostate cancer are limited to a few small studies. There are no prior studies reporting experiences with transplantation in men with PCa who have been treated with cryotherapy. The objective of this study was to report on outcomes for patients who had undergone prostate cryotherapy at our institution, either before or after solid organ transplantation. This study represents the first in the medical literature of transplant patients with PCa who have undergone prostate cryotherapy. METHODS: A retrospective patient chart and Institutional Review Board (IRB) approved cryoablation database review of 900 consecutive cases of prostate cryoablation conducted between 1994 and 2010 at a single academic institution was performed. Those who had undergone a solid organ transplant before or after cryoablation were identifed. Data on relevant pre-, intra- and post treatment information was retrospectively reviewed. Data was collected on time interval from PCa diagnosis and prostate cryotherapy to transplantation or vice versa, immunosuppressive medication, biochemical and clinical recurrence rates and mortality (categorized as prostate cancer specific, transplant-related or unrelated mortality).
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
RESULTS: Seven patients who were or had been on the transplant register who had prostate cryotherapy for PCa were identified: 4 cardiac and 3 renal transplant recipients. Mean age at PCa diagnosis was 64.2 (50 –78) years. Median preoperative PSA 9.2 (5.2–20.2) ng/ml. Mean Gleason score 7 (6 – 8). 4 were transplanted before undergoing prostate cryotherapy (3 cardiac, 1 renal). 3 were transplanted after having had prostate cryotherapy (1 cardiac, 2 renal). There were no PCa or transplantrelated deaths. The only death was in a cardiac transplant recipient who died of lung adenocarcinoma 9 years after prostate cryotherapy, with an undetectable PSA at the time of death. CONCLUSIONS: In conclusion, prostate cryotherapy is feasible as a minimally invasive treatment option for PCa in solid organ transplant recipients. Prostate cryotherapy is also a good PCa treatment option men awaiting transplantation, who require PCa treatment in order to meet the criteria for remaining on the transplant register. Source of Funding: None
1004 10 YEAR OUTCOME AND MORBIDITY OF HIGH-INTENSITY FOCUSSED ULTRASOUND (HIFU) AS A PRIMARY THERAPY FOR LOCALIZED PROSTATE CANCER: OUTCOMES FROM 2552 MEN FOLLOWED WITH THE @-REGISTRY Roman Ganzer*, Regensburg, Germany; Antonell Paulesu, Como, Italy; Viktor Berge, Oslo, Norway; Andreas Blana, Fuerth, Germany; Stephen Brown, Stockport, United Kingdom; Christian Chaussy, munich, Germany; Sebastien Crouzet, Lyon, France; John F. Ward, Houston, TX; Stephan Thueroff, Munich, Germany; Cary N. Robertson, Durham, NC INTRODUCTION AND OBJECTIVES: The utilization of HIFU as a primary therapy for prostate cancer continues to increase. The objective of this study is to report 10 year biochemical and biopsy outcomes of patients who have undergone HIFU and were followed with the @-Registry. This is the largest HIFU series ever reported. METHODS: The @-Registry is a secure on-line database consisting of case report forms, which collect relevant data from patients undergoing prostate HIFU. Those patients with stage T1-3 prostate cancer who had undergone HIFU with Ablatherm (EDAP-TMS, Lyon, France) and had at least one PSA follow-up recorded following achievement of a nadir were included in the analysis. Patients were stratified according to D’Amico’s 2003 risk groups. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined according to the 2006 Phoenix definition (nadir⫹2). Biopsy data was also analyzed as was post treatment morbidity. RESULTS: A total of 2552 consecutive patients met the inclusion criteria. The average age was 70.1 ⫾ 6.5 years. Pre treatment PSA was 10.2 ⫾ 12.6 ng/ml, the median Gleason sum was 6 and 30.6%, 39.4% and 30.0% of patients were in the low, moderate and high risk group, respectively. Patients were followed for 39.6 ⫾ 31.2 (range: 3 to 193) months. The median PSA nadir was 0.11 ng/ml which was reached 12.9 ⫾ 11.1 weeks after HIFU. Actuarial survivals at 5 and 10 years and biopsy data are reported in the table. Grade I, II and III incontinence was observed in 12.4%, 6.4% and 1.8% of the population, respectively. The stenosis rate was 18.5% and the retention rate was 11.0%. Potency data was inconsistent and is not presented herein. CONCLUSIONS: HIFU provides good biochemical control through 10 years of follow-up with a mild morbidity profile. Negative biopsy rates are high across all risk groups. These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option. 5-year BDFS 76%
10-year BDFS 56%
negative Bx rate 83%
low-risk
84%
63%
89.3%
moderate-risk
77%
54%
81.2%
high-risk
68%
55%
78.3%
all patients
Source of Funding: None
THE JOURNAL OF UROLOGY姞
1002 EXAMINING AN INTERACTIVE, MULTIMEDIA EDUCATION AND DECISION PROGRAM FOR EARLY-STAGE PROSTATE CANCER PATIENTS Michael Diefenbach*, Nihal Mohamed, Simon Hall, New York, NY INTRODUCTION AND OBJECTIVES: Treatment options for localized prostate cancer (CaP) are characterized by excellent 5-yr survival prospects, but varying implications for quality of life. Thus, there is a need for extensive patient education for treatment decision making. We developed an Internet-based multimedia CaP educational software (PIES) that provides patients with information about CaP and its treatment through an intuitive interface, using video, animation, and text. We used the metaphor of a virtual health center to present the information. The current study evaluates the efficacy of PIES in facilitating decision making. We hypothesize that PIES will reduce decisional conflict and increase confidence in the treatment decision compared to standard care. METHODS: Patients diagnosed with localized CaP who had not made a treatment decision were randomized into 3 groups: a) Standard care receiving NCI print materials (n ⫽ 24); b) PIES with information tailored to information seeking preference (n ⫽ 39); c) PIES without tailored information (n ⫽ 27). We administrated questionnaires before the intervention (t1), following the intervention (t2), and six weeks later (t3). Measurements include the Decisional Conflict Scale (i.e., uncertainty in choosing options, informed decision, value clarification, decisional support, O’Connor, 1995) and measures to assess confidence in the decision and emotional impact of the information (Diefenbach et al., 2002). RESULTS: Patients were on average 60 years (SD ⫽ 1.18), white and married. There were no differences in outcome variables between the tailored and non-tailored PIES groups, thus they were combined (n ⫽ 66). At t2 the combined PIES group, compared to standard care, reported a significant increase in confidence to make a treatment decision, indicated that their decision was more congruent with their values, and experienced the information as more reassuring and less distressing (all ps ⬍ .05). Comparisons between baseline and the six weeks follow-up assessment showed that these effects persisted as patients in the PIES group continued to be better informed about their options, displayed reduced decisional uncertainty, and were better informed about the benefits that mattered most to them, compared to the standard care group. CONCLUSIONS: Using PIES prior to making a treatment decision leads to reduced decisional conflict, increased confidence, and a value concordant decision. Source of Funding: DAMD W81 XWH-04-1-0179
1003 PROSTATE CRYOABLATION BEFORE AND AFTER SOLID ORGAN TRANSPLANTATION Philippa Cheetham*, Scott Stevenson, Zahid Saeed, Max Pitman, Elton Llukani, Aaron Katz, New York, NY INTRODUCTION AND OBJECTIVES: Prostate cancer (PCa) is being diagnosed with increasing frequency due to routine PSA screening. To date, reported experiences with transplantation in men with a history of prostate cancer are limited to a few small studies. There are no prior studies reporting experiences with transplantation in men with PCa who have been treated with cryotherapy. The objective of this study was to report on outcomes for patients who had undergone prostate cryotherapy at our institution, either before or after solid organ transplantation. This study represents the first in the medical literature of transplant patients with PCa who have undergone prostate cryotherapy. METHODS: A retrospective patient chart and Institutional Review Board (IRB) approved cryoablation database review of 900 consecutive cases of prostate cryoablation conducted between 1994 and 2010 at a single academic institution was performed. Those who had undergone a solid organ transplant before or after cryoablation were identifed. Data on relevant pre-, intra- and post treatment information was retrospectively reviewed. Data was collected on time interval from PCa diagnosis and prostate cryotherapy to transplantation or vice versa, immunosuppressive medication, biochemical and clinical recurrence rates and mortality (categorized as prostate cancer specific, transplant-related or unrelated mortality).
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
RESULTS: Seven patients who were or had been on the transplant register who had prostate cryotherapy for PCa were identified: 4 cardiac and 3 renal transplant recipients. Mean age at PCa diagnosis was 64.2 (50 –78) years. Median preoperative PSA 9.2 (5.2–20.2) ng/ml. Mean Gleason score 7 (6 – 8). 4 were transplanted before undergoing prostate cryotherapy (3 cardiac, 1 renal). 3 were transplanted after having had prostate cryotherapy (1 cardiac, 2 renal). There were no PCa or transplantrelated deaths. The only death was in a cardiac transplant recipient who died of lung adenocarcinoma 9 years after prostate cryotherapy, with an undetectable PSA at the time of death. CONCLUSIONS: In conclusion, prostate cryotherapy is feasible as a minimally invasive treatment option for PCa in solid organ transplant recipients. Prostate cryotherapy is also a good PCa treatment option men awaiting transplantation, who require PCa treatment in order to meet the criteria for remaining on the transplant register. Source of Funding: None
1004 10 YEAR OUTCOME AND MORBIDITY OF HIGH-INTENSITY FOCUSSED ULTRASOUND (HIFU) AS A PRIMARY THERAPY FOR LOCALIZED PROSTATE CANCER: OUTCOMES FROM 2552 MEN FOLLOWED WITH THE @-REGISTRY Roman Ganzer*, Regensburg, Germany; Antonell Paulesu, Como, Italy; Viktor Berge, Oslo, Norway; Andreas Blana, Fuerth, Germany; Stephen Brown, Stockport, United Kingdom; Christian Chaussy, munich, Germany; Sebastien Crouzet, Lyon, France; John F. Ward, Houston, TX; Stephan Thueroff, Munich, Germany; Cary N. Robertson, Durham, NC INTRODUCTION AND OBJECTIVES: The utilization of HIFU as a primary therapy for prostate cancer continues to increase. The objective of this study is to report 10 year biochemical and biopsy outcomes of patients who have undergone HIFU and were followed with the @-Registry. This is the largest HIFU series ever reported. METHODS: The @-Registry is a secure on-line database consisting of case report forms, which collect relevant data from patients undergoing prostate HIFU. Those patients with stage T1-3 prostate cancer who had undergone HIFU with Ablatherm (EDAP-TMS, Lyon, France) and had at least one PSA follow-up recorded following achievement of a nadir were included in the analysis. Patients were stratified according to D’Amico’s 2003 risk groups. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined according to the 2006 Phoenix definition (nadir⫹2). Biopsy data was also analyzed as was post treatment morbidity. RESULTS: A total of 2552 consecutive patients met the inclusion criteria. The average age was 70.1 ⫾ 6.5 years. Pre treatment PSA was 10.2 ⫾ 12.6 ng/ml, the median Gleason sum was 6 and 30.6%, 39.4% and 30.0% of patients were in the low, moderate and high risk group, respectively. Patients were followed for 39.6 ⫾ 31.2 (range: 3 to 193) months. The median PSA nadir was 0.11 ng/ml which was reached 12.9 ⫾ 11.1 weeks after HIFU. Actuarial survivals at 5 and 10 years and biopsy data are reported in the table. Grade I, II and III incontinence was observed in 12.4%, 6.4% and 1.8% of the population, respectively. The stenosis rate was 18.5% and the retention rate was 11.0%. Potency data was inconsistent and is not presented herein. CONCLUSIONS: HIFU provides good biochemical control through 10 years of follow-up with a mild morbidity profile. Negative biopsy rates are high across all risk groups. These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option. 5-year BDFS 76%
10-year BDFS 56%
negative Bx rate 83%
low-risk
84%
63%
89.3%
moderate-risk
77%
54%
81.2%
high-risk
68%
55%
78.3%
all patients
Source of Funding: None