- Email: [email protected]
PO-0671 STEREOTACTIC BODY RADIOTHERAPY BOOST FOR TREATMENT OF ORGAN-CONFINED PROSTATE CANCER
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these patients can cause many side effects. The data we present could be helpful when discussing therapeutic options with patients. Source of Funding: AstraZeneca Pharmaceuticals grant PO-0669 BOWEL TOXICITY AFTER IMRT FOR PROSTATE CANCER WITH A SPACER GEL - A MATCHED-PAIR COMPARISON M. Pinkawa1, R. Holy1, M.D. Piroth1, J. Klotz1, V. Djukic1, S. Schaar1, M.J. Eble1 1 Univ. Klinikum der RWTH Aachen, Radiation Oncology Department, Aachen, Germany Purpose/Objective: The aim of the study was to compare acute bowel quality of life changes after intensity modulated radiotherapy (IMRT) with a spacer gel (mechanical protection of rectal wall) in comparison to low (dosimetric protection of rectal wall) and high dose radiotherapy without a spacer gel. Materials and Methods: A group of 84 patients (28 in each group) has been surveyed prospectively before RT (time A), at the last day of RT (time B) and 2-3 months after RT (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite; only patients who responded to all questionnaires included). The multiitem scale scores were transformed lineary to a 0-100 scale, with higher scores representing better quality of life. Score changes were calculated for the individual domains and additionally for each bowel bother item. Mean changes/differences of at least 5 points were defined as clinically relevant. The total dose to the prostate in the spacer subgroup (SP) was 76-78Gy in 2Gy fractions. The SpaceOARTM maintains space for approximately three months and is absorbed in approximately six months. Low and high dose RT included 3D conformal treatment up to 70.2Gy in 1.8Gy fractions (LD) and IMRT up to 76Gy in 2Gy fractions (HD), respectively. Pairs were matched according to following criteria: age, prostate volume, bowel bother score before RT, prognostic risk subgroup and use of antiandrogens. Results: Mean bowel bother scores of 96 points were calculated in all subgroups before treatment. Nearly identical mean changes (SP: 16, LD: 14, HD: 17 points) resulted at the end of RT, but the best results in the spacer subgroup 2-3 months after RT (SP: 2, LD: 8, HD: 6 points). Bowel bother scores have not been statistically significantly different at time C in comparison to baseline levels only in the spacer subgroup. Clinically relevant greater bother was found for the items 'losing control of stools' and 'bloody stools' in the spacer subgroup in comparison to both other groups at the end of RT, but less bother for the items 'rectal urgency', 'increased frequency of bowel movements' and 'bowel habits overall' in comparison to the high dose subgroup. At time C, clinically relevant less bother resulted only for patients in the spacer subgroup in comparison to the other subgroups (LD/HD: 'rectal urgency', LD: 'watery bowel movements', 'bloody stools', 'rectal pain'; HD: 'losing control of stools', 'bowel habits overall'). Conclusions: Moderate bowel quality of life changes can be expected during a radiotherapy treatment course irrespectively of the application of a spacer or the total dose. Advantages following radiotherapy with a spacer can be expected a few weeks after treatment and presumably in the long term. PO-0670 CAPORT STUDY: PROSTATE CANCER PATIENT PROFILE IN THE RADIATION ONCOLOGY CONSULTATION X. Maldonado1, J.L. Torrecilla2, A. Zapatero3, R. Jimenez4, J. Lozano5, J. Muñoz6, A.M. Pérez7, I. Rodriguez8, C. Ferrer9 1 Hospital Universitari Vall d´Hebron, Radiation Oncology, Barcelona, Spain 2 Hospital General Universitario, Radiation Oncology-ERESA, Valencia, Spain 3 Hospital Universitario de la Princesa, Radiation Oncology, Madrid, Spain 4 Centro Radioncológico Andaluz S.A, Radiation Oncology, Málaga, Spain 5 Hospital de l´Esperança, Radiation Oncology, Barcelona, Spain 6 Hospital Infanta Cristina, Radiation Oncology, Badajoz, Spain 7 Fundación Jimenez Díaz, Radiation Oncology, Madrid, Spain 8 Hospital de Campo Grande, Radiation Oncology, Valladolid, Spain 9 Hospital Provincial de Castellón, Radiation Oncology, Castellón, Spain Purpose/Objective: To assess the real clinical profile of prostate cancer (PC) patients visiting Radiation Oncologists (RO) for the first time.
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Materials and Methods: The GICOR and URONCOR groups promoted a prospective, epidemiological, non-interventionist, cross-sectional study in 59 RO departments in Spain. Under conditions of daily clinical practice, an ad-hoc questionnaire was completed for 6 prospective PC patients who came for a first-time RO consultation.The information was focused on demographic and co-morbidity characteristics, diagnostic procedures, clinical staging, additional tests, quality of life and indication for consultation.The statistical analysis was performed using the STATA statistical package. Measures of central tendency, dispersion, and percentiles (p25 and p75) were calculated for quantitative variables. Results: Three hundred and forty-three (343) patients were analyzed. Mean age was 69 years (range 48 - 88); median PSA 8.2 ng/ml and median prostate volume 40 cc. Mean IPSS score was 8. PC familial history was present in 15% of patients. Median biopsied and positives cores were 9 (SD 3.3) and 3 (SD 2.5), respectively. Gleason scores rates were: 54% for Gleason ≤ 6, 33% for Gleason 7 and 13% for Gleason> 7. According to the NCCN 2010 PC risk classification, 31% were low risk, 41% intermediate risk, 24% high-very high risk and 4% disseminated. TNM was T1-T2 N0 M0 in 80% of the population. In 73.76% of the cases additional tests were performed to confirm PC diagnosis (CT 64%, bone scan 64%, MRI 35% and PET CT 1%) with very low outcomes except for MRI (65% pathological). Ninety-one percent (91%) of the patients were referred from Urology and 5% from Medical Oncology. In 93% of the cases, the patient learnt about the RO through another healthcare professional. The indications for consultation were: 78% curative intent, 17% postoperative (21% adjuvant, 76% PSA failure, 3% local relapse), 3% palliative and 2% for a second opinion. The clinical staging by the referring physician and the RO matched, although the RO was more accurate: Tx (16% vs 11%), Nx (22% vs 13%) and Mx (19% vs 11%). At the time of the visit 66% had erectile dysfunction, 17% mild urinary incontinence. The main reported co-morbidities were: 46% hypertension, 23% diabetes mellitus, 38.5% dyslipidemia and 20% CV diseases. Mean Charlson Index: 0.84 (SD 1.2). 53% needed > 2 drugs, whereas 20% were taking drugs for lower urinary tract symptoms (LUTS)and 36% for PC. Conclusions: The profile of the PC patient referred for consultation to RO for the first time is: primarily referred from Urology for a treatment with curative intent, but previously treated in 36% of cases; diagnosed to the age of 70 with a Gleason score 6-7, and a predominance of intermediate-risk localized disease. Co-morbidities are present in almost half of the population requiring drugs. Two thirds of patients present moderate-severe erectile dysfunction and 20% are taking drugs for LUTS. PO-0671 STEREOTACTIC BODY RADIOTHERAPY BOOST FOR TREATMENT OF ORGAN-CONFINED PROSTATE CANCER A. Katz1, M. Santoro1 1 Flushing Radiation Oncology, Cyberknife, Flushing, USA Purpose/Objective: CyberKnife stereotactic body radiotherapy (SBRT) for prostate cancer allows safe delivery of doses and fractions comparable to high-dose-rate (HDR) brachytherapy. The purpose of this study is to assess the effects of using SBRT as a boost to external beam radiation therapy (EBRT) for patients with intermediate- and high-risk prostate cancer. Materials and Methods: Patients had intermediate- (Gleason score 7; PSA < 20 and > 10) or high-risk (Gleason Score ≥ 8 or a PSA > 20 ng/ml) prostate cancer with negative bone scans. All patients received 45 Gy EBRT followed by a CyberKnife-delivered SBRT boost of 3 fractions of 6 (36.8% of patients), 6.5 (38.1% of patients) or 7 (25.0% of patients) Gy each. Amifostine (1500 mg) was delivered intrarectally prior to SBRT fractions. SBRT was prescribed to the 83-87% isodose line with 5mm margins added to the gross tumor volume at all borders except for 3 mm at the rectum. Four gold fiducial seeds were continuously tracked during sessions of approximately 40 minutes' duration. Toxicity was assessed using the Radiation Therapy Oncology Group urinary and rectal toxicity scale. Biochemical failure was assessed using the Phoenix definition. Results: From April 2006 through January 2008, 76 patients (40 intermediate- & 36 high-risk) with clinically localized prostate cancer were treated with EBRT followed by SBRT boost. The median followup was 55 months (range, 12 - 68 months). Four patients were lost to follow-up and 6 patients died from causes other than their disease. Fewer than 7% of patients had acute Grade II toxicity and no higher grade acute toxicities occurred. Late Grade II urinary and rectal
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toxicity occurred in 5% and 9% of patients, respectively. One Grade III late urinary toxicity occurred. The median PSA was 0.12 ng/ml at 48 months. Five intermediate-risk and nine high-risk biochemical failures occurred; one high-risk patient died from prostate cancer 16 months after treatment. The 5-year actuarial biochemical freedom from failure rate was 87% and 75% for the intermediate- and high-risk patients, respectively. Conclusions: At 55 months median follow-up, the toxicity and efficacy of CyberKnife delivered SBRT boost for intermediate- and high-risk prostate cancer treatment are comparable to 5-year HDR brachytherapy boost results. Since our treatments were homogeneous,these results suggest that dose escalation achieved by SBRT treatment with hypofractionation, rather than dose heterogeneity inherent in HDR, may account for HDR brachytherapy's excellent clinical outcomes. PO-0672 QUALITY OF LIFE IN PROSTATE CANCER PATIENTS: RADIOTHERAPY COMPARED TO ACTIVE SURVEILLANCE L. Bellardita1, B. Avuzzi1, T. Rancati1, D. Villani2, S. Catania1, T. Magnani1, S. Villa3, N. Bedini3, S. Morlino3, R. Valdagni4 1 Fondazione IRCCS Istituto Nazionale dei Tumori, Prostate Cancer Program, Milan, Italy 2 Dept of Psychology, Università Cattolica, Milan, Italy 3 Fondazione IRCCS Istituto Nazionale dei Tumori, Dept of Radiotherapy 1, Milan, Italy 4 Fondazione IRCCS Istituto Nazionale dei Tumori, Prostate Cancer Program and Dept of Radiotherapy 1, Milan, Italy Purpose/Objective: The aim of this study is to evaluate baseline Health-Related QoL (HRQoL) and adjustment to cancer in patients (pts) with localised PCa undergoing external beam RT and to compare it with pts who choose Active Surveillance (AS). Materials and Methods: RT pts (n=38, median age 70yrs; 12 low-risk pts, 9 intermediate-risk pts and 17 high-risk pts) and pts who chose AS observational strategy (n=88, median age 67.5 yrs; all cT1–2, GPS=6) were assessed prior to either treatment or entrance in Active Surveillance (PRIAS) protocol. Self-report questionnaires were administered, including: - Functional Assessment of Cancer Therapy – Prostate Version (FACTP), assessing Health-related QoL in terms of physical well-being, social well-being (SWB), emotional well-being (EWB), functional wellbeing (FWB) and wellbeing related to prostate cancer symptoms (PCS); scores > 3 identify a very high level of wellbeing within the considered area. - Mini-Mental Adjustment to Cancer Scale (Mini-MAC), assessing style of adjustment to cancer in terms of fighting spirit (FS), anxious preoccupation (AP), helplessness/hopelessness (HH), fatalism (FA) and avoidance (AV); scores > 2 imply a presence of the disease adjustment style considered. Results: Both pts who chose RT and AS pts reported very high levels of PWB (92% and 97% respectively), EWB (66% and 54% respectively) and PCS (66% and 76% respectively). A few pts achieved very high FWB (18% and 27% respectively). RT and AS pts reported presence of FS (87% in both groups) and FA (66% and 61% respectively), no disease-related AP (76% and 72% respectively), no sense of HH (92% and 93% respectively) and no AV behaviour (71% and 62% respectively). The statistical differences between the mean scores were evaluated with Student t-test. Results showed that SWB (p=0.0001) and PCS (p=0.027) were statistically lower in the RT group (SWB: mean=2.57+/-0.84; PCS: mean=3.07+/-0.48) than in AS (SWB: mean=3.08+/-0.64; PCS: mean=3.25+/-0.39). These differences between the compared groups didn’t reach clinical relevance, defined as the minimal important difference of half the standard deviation. Conclusions: HRQoL was very high in both groups of pts, except for FWB. The low level of FWB (i.e. limitations in the performance of social roles or activities) before starting therapies is counterintuitive and subscale validity should be further investigated on a larger sample. Adjustment to cancer was positive in both RT and AS pts. To conclude, PCa pts who choose RT report a good level of QoL, comparable with that of pts undergoing AS. Further work is being done to evaluate HRQoL after RT treatment Acknowledgements to I. Monzino and ProADAMO Foundations for founding psychological support for PCa patients.
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PO-0673 ACTIVE SURVEILLANCE FOR LOW-RISK PROSTATE CANCER: PRACTICE AMONGST UROLOGISTS FROM FOUR EUROPEAN COUNTRIES A. Azmi1, R. Dillon2, S. Borghesi3, M. Dunne4, R. Power5, R. Marignol2, B.D.P. O'Neill1 1 St. Luke's Radiation Oncology Network, Department of Radiation Oncology, Dublin, Ireland Republic of 2 Trinity College Dublin, Division of Radiation Therapy, Dublin, Ireland Republic of 3 Radiotherapy Unit, San Donato Hospital, Arezzo, Italy 4 St. Luke's Hospital, Clinical Trials Unit, Dublin, Ireland Republic of 5 Beaumont Hospital, Department of Urology, Dublin, Ireland Republic of Purpose/Objective: Active surveillance (AS) is a recognized treatment option for low-risk prostate cancer (PCa). The optimal AS strategy is undefined. We carried out a web-based survey to evaluate how AS is practiced amongst European Urologists. Materials and Methods: 2959 potential participants were identified via various European urological association databases and invited via email to complete an online survey about their practice of AS including eligibility criteria, follow-up protocols and triggers for intervention. Analyses were conducted on the four countries with the most responses. The Chi-square test was used to compare groups. Statistical analyses were carried out using SPSS version 18.0. Results: The countries with the most responses are Italy (n=49), the UK (n=42), the Netherlands (n=18) and France (n=15). 96% of respondents from these countries offer AS as a treatment option. 56% use an official protocol and 32% offer AS as part of a clinical trial. There is a significant association between country of practice and using an official AS protocol (p=0.044) and participating in a clinical trial (p=0.001). Urologists in the Netherlands were the most likely to use an official AS protocol (83%) and to offer AS within a clinical trial (67%). The Urologists are in relative agreement that a PSA ≤ 10ng/ml (74 to 100%) and Gleason score 3+3=6 (63 to 100%) are used as eligibility criteria. There is less agreement with respect to age, clinical stage and the percent or number of biopsy cores involved. There is a significant association between performing an MRI prior to enrolling patients in AS and country of practice (p<0.001), with Urologists in France (73%) and the UK (69%) being most likely to carry this out. Follow-up protocols vary both within each country and between the four countries. There is a significant association between country of practice and using symptomatic disease progression (p=0.012), >50% of any core involved (p=0.015) and >2 cores involved (p=0.002) on repeat biopsy as trigger factors for radical treatment. Urologists in France and Italy were most likely to use symptomatic disease progression and >50% of any core involved as trigger factors while Urologists in the UK were least likely to use >2 cores involved on repeat biopsy as a trigger for intervention. Conclusions: This survey highlights the wide variation in the practice of AS amongst European Urologists from four European countries. Further studies are required to determine the optimal AS strategy and Clinicians are encouraged to enrol their patients in clinical trials to enable an evidence-based guideline to be established. PO-0674 POST-OP PROSTATE RADIOTHERAPY: THE CASE OF THE MISSING TARGET, MYSTERY SOLVED J.M. Croke1, B. Nyri2, Y. Li1, L. Avruch3, E. Belanger4, C. Morash5, C. Kayser1, K. Malone1, S. Malone1 1 The Ottawa Hospital Cancer Centre, Radiation Oncology, Ottawa, Canada 2 The Ottawa Hospital Cancer Centre, Medical Physics, Ottawa, Canada 3 The Ottawa Hospital, Diagnostic Imaging, Ottawa, Canada 4 The Ottawa Hospital, Anatomical Pathology, Ottawa, Canada 5 The Ottawa Hospital, Urology, Ottawa, Canada Purpose/Objective: Postoperative radiotherapy (RT) increases survival in high-risk (pT3, margin positive) prostate cancer (PCa) patients (pts). Despite the benefit of adjuvant RT approximately 50% of pts relapse in long-term follow-up, with the primary site of failure being local (SWOG 8794). The EORTC and RTOG have published consensus guidelines to delineate post-op CTV for PCa. The study objectives were: 1. To compare CTV EORTC and CTV RTOG to preoperative MRI defined prostate and gross tumour. 2. To create a modified CTV (CTV TOH) that incorporates pre-op MRI.
these patients can cause many side effects. The data we present could be helpful when discussing therapeutic options with patients. Source of Funding: AstraZeneca Pharmaceuticals grant PO-0669 BOWEL TOXICITY AFTER IMRT FOR PROSTATE CANCER WITH A SPACER GEL - A MATCHED-PAIR COMPARISON M. Pinkawa1, R. Holy1, M.D. Piroth1, J. Klotz1, V. Djukic1, S. Schaar1, M.J. Eble1 1 Univ. Klinikum der RWTH Aachen, Radiation Oncology Department, Aachen, Germany Purpose/Objective: The aim of the study was to compare acute bowel quality of life changes after intensity modulated radiotherapy (IMRT) with a spacer gel (mechanical protection of rectal wall) in comparison to low (dosimetric protection of rectal wall) and high dose radiotherapy without a spacer gel. Materials and Methods: A group of 84 patients (28 in each group) has been surveyed prospectively before RT (time A), at the last day of RT (time B) and 2-3 months after RT (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite; only patients who responded to all questionnaires included). The multiitem scale scores were transformed lineary to a 0-100 scale, with higher scores representing better quality of life. Score changes were calculated for the individual domains and additionally for each bowel bother item. Mean changes/differences of at least 5 points were defined as clinically relevant. The total dose to the prostate in the spacer subgroup (SP) was 76-78Gy in 2Gy fractions. The SpaceOARTM maintains space for approximately three months and is absorbed in approximately six months. Low and high dose RT included 3D conformal treatment up to 70.2Gy in 1.8Gy fractions (LD) and IMRT up to 76Gy in 2Gy fractions (HD), respectively. Pairs were matched according to following criteria: age, prostate volume, bowel bother score before RT, prognostic risk subgroup and use of antiandrogens. Results: Mean bowel bother scores of 96 points were calculated in all subgroups before treatment. Nearly identical mean changes (SP: 16, LD: 14, HD: 17 points) resulted at the end of RT, but the best results in the spacer subgroup 2-3 months after RT (SP: 2, LD: 8, HD: 6 points). Bowel bother scores have not been statistically significantly different at time C in comparison to baseline levels only in the spacer subgroup. Clinically relevant greater bother was found for the items 'losing control of stools' and 'bloody stools' in the spacer subgroup in comparison to both other groups at the end of RT, but less bother for the items 'rectal urgency', 'increased frequency of bowel movements' and 'bowel habits overall' in comparison to the high dose subgroup. At time C, clinically relevant less bother resulted only for patients in the spacer subgroup in comparison to the other subgroups (LD/HD: 'rectal urgency', LD: 'watery bowel movements', 'bloody stools', 'rectal pain'; HD: 'losing control of stools', 'bowel habits overall'). Conclusions: Moderate bowel quality of life changes can be expected during a radiotherapy treatment course irrespectively of the application of a spacer or the total dose. Advantages following radiotherapy with a spacer can be expected a few weeks after treatment and presumably in the long term. PO-0670 CAPORT STUDY: PROSTATE CANCER PATIENT PROFILE IN THE RADIATION ONCOLOGY CONSULTATION X. Maldonado1, J.L. Torrecilla2, A. Zapatero3, R. Jimenez4, J. Lozano5, J. Muñoz6, A.M. Pérez7, I. Rodriguez8, C. Ferrer9 1 Hospital Universitari Vall d´Hebron, Radiation Oncology, Barcelona, Spain 2 Hospital General Universitario, Radiation Oncology-ERESA, Valencia, Spain 3 Hospital Universitario de la Princesa, Radiation Oncology, Madrid, Spain 4 Centro Radioncológico Andaluz S.A, Radiation Oncology, Málaga, Spain 5 Hospital de l´Esperança, Radiation Oncology, Barcelona, Spain 6 Hospital Infanta Cristina, Radiation Oncology, Badajoz, Spain 7 Fundación Jimenez Díaz, Radiation Oncology, Madrid, Spain 8 Hospital de Campo Grande, Radiation Oncology, Valladolid, Spain 9 Hospital Provincial de Castellón, Radiation Oncology, Castellón, Spain Purpose/Objective: To assess the real clinical profile of prostate cancer (PC) patients visiting Radiation Oncologists (RO) for the first time.
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Materials and Methods: The GICOR and URONCOR groups promoted a prospective, epidemiological, non-interventionist, cross-sectional study in 59 RO departments in Spain. Under conditions of daily clinical practice, an ad-hoc questionnaire was completed for 6 prospective PC patients who came for a first-time RO consultation.The information was focused on demographic and co-morbidity characteristics, diagnostic procedures, clinical staging, additional tests, quality of life and indication for consultation.The statistical analysis was performed using the STATA statistical package. Measures of central tendency, dispersion, and percentiles (p25 and p75) were calculated for quantitative variables. Results: Three hundred and forty-three (343) patients were analyzed. Mean age was 69 years (range 48 - 88); median PSA 8.2 ng/ml and median prostate volume 40 cc. Mean IPSS score was 8. PC familial history was present in 15% of patients. Median biopsied and positives cores were 9 (SD 3.3) and 3 (SD 2.5), respectively. Gleason scores rates were: 54% for Gleason ≤ 6, 33% for Gleason 7 and 13% for Gleason> 7. According to the NCCN 2010 PC risk classification, 31% were low risk, 41% intermediate risk, 24% high-very high risk and 4% disseminated. TNM was T1-T2 N0 M0 in 80% of the population. In 73.76% of the cases additional tests were performed to confirm PC diagnosis (CT 64%, bone scan 64%, MRI 35% and PET CT 1%) with very low outcomes except for MRI (65% pathological). Ninety-one percent (91%) of the patients were referred from Urology and 5% from Medical Oncology. In 93% of the cases, the patient learnt about the RO through another healthcare professional. The indications for consultation were: 78% curative intent, 17% postoperative (21% adjuvant, 76% PSA failure, 3% local relapse), 3% palliative and 2% for a second opinion. The clinical staging by the referring physician and the RO matched, although the RO was more accurate: Tx (16% vs 11%), Nx (22% vs 13%) and Mx (19% vs 11%). At the time of the visit 66% had erectile dysfunction, 17% mild urinary incontinence. The main reported co-morbidities were: 46% hypertension, 23% diabetes mellitus, 38.5% dyslipidemia and 20% CV diseases. Mean Charlson Index: 0.84 (SD 1.2). 53% needed > 2 drugs, whereas 20% were taking drugs for lower urinary tract symptoms (LUTS)and 36% for PC. Conclusions: The profile of the PC patient referred for consultation to RO for the first time is: primarily referred from Urology for a treatment with curative intent, but previously treated in 36% of cases; diagnosed to the age of 70 with a Gleason score 6-7, and a predominance of intermediate-risk localized disease. Co-morbidities are present in almost half of the population requiring drugs. Two thirds of patients present moderate-severe erectile dysfunction and 20% are taking drugs for LUTS. PO-0671 STEREOTACTIC BODY RADIOTHERAPY BOOST FOR TREATMENT OF ORGAN-CONFINED PROSTATE CANCER A. Katz1, M. Santoro1 1 Flushing Radiation Oncology, Cyberknife, Flushing, USA Purpose/Objective: CyberKnife stereotactic body radiotherapy (SBRT) for prostate cancer allows safe delivery of doses and fractions comparable to high-dose-rate (HDR) brachytherapy. The purpose of this study is to assess the effects of using SBRT as a boost to external beam radiation therapy (EBRT) for patients with intermediate- and high-risk prostate cancer. Materials and Methods: Patients had intermediate- (Gleason score 7; PSA < 20 and > 10) or high-risk (Gleason Score ≥ 8 or a PSA > 20 ng/ml) prostate cancer with negative bone scans. All patients received 45 Gy EBRT followed by a CyberKnife-delivered SBRT boost of 3 fractions of 6 (36.8% of patients), 6.5 (38.1% of patients) or 7 (25.0% of patients) Gy each. Amifostine (1500 mg) was delivered intrarectally prior to SBRT fractions. SBRT was prescribed to the 83-87% isodose line with 5mm margins added to the gross tumor volume at all borders except for 3 mm at the rectum. Four gold fiducial seeds were continuously tracked during sessions of approximately 40 minutes' duration. Toxicity was assessed using the Radiation Therapy Oncology Group urinary and rectal toxicity scale. Biochemical failure was assessed using the Phoenix definition. Results: From April 2006 through January 2008, 76 patients (40 intermediate- & 36 high-risk) with clinically localized prostate cancer were treated with EBRT followed by SBRT boost. The median followup was 55 months (range, 12 - 68 months). Four patients were lost to follow-up and 6 patients died from causes other than their disease. Fewer than 7% of patients had acute Grade II toxicity and no higher grade acute toxicities occurred. Late Grade II urinary and rectal
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toxicity occurred in 5% and 9% of patients, respectively. One Grade III late urinary toxicity occurred. The median PSA was 0.12 ng/ml at 48 months. Five intermediate-risk and nine high-risk biochemical failures occurred; one high-risk patient died from prostate cancer 16 months after treatment. The 5-year actuarial biochemical freedom from failure rate was 87% and 75% for the intermediate- and high-risk patients, respectively. Conclusions: At 55 months median follow-up, the toxicity and efficacy of CyberKnife delivered SBRT boost for intermediate- and high-risk prostate cancer treatment are comparable to 5-year HDR brachytherapy boost results. Since our treatments were homogeneous,these results suggest that dose escalation achieved by SBRT treatment with hypofractionation, rather than dose heterogeneity inherent in HDR, may account for HDR brachytherapy's excellent clinical outcomes. PO-0672 QUALITY OF LIFE IN PROSTATE CANCER PATIENTS: RADIOTHERAPY COMPARED TO ACTIVE SURVEILLANCE L. Bellardita1, B. Avuzzi1, T. Rancati1, D. Villani2, S. Catania1, T. Magnani1, S. Villa3, N. Bedini3, S. Morlino3, R. Valdagni4 1 Fondazione IRCCS Istituto Nazionale dei Tumori, Prostate Cancer Program, Milan, Italy 2 Dept of Psychology, Università Cattolica, Milan, Italy 3 Fondazione IRCCS Istituto Nazionale dei Tumori, Dept of Radiotherapy 1, Milan, Italy 4 Fondazione IRCCS Istituto Nazionale dei Tumori, Prostate Cancer Program and Dept of Radiotherapy 1, Milan, Italy Purpose/Objective: The aim of this study is to evaluate baseline Health-Related QoL (HRQoL) and adjustment to cancer in patients (pts) with localised PCa undergoing external beam RT and to compare it with pts who choose Active Surveillance (AS). Materials and Methods: RT pts (n=38, median age 70yrs; 12 low-risk pts, 9 intermediate-risk pts and 17 high-risk pts) and pts who chose AS observational strategy (n=88, median age 67.5 yrs; all cT1–2, GPS=6) were assessed prior to either treatment or entrance in Active Surveillance (PRIAS) protocol. Self-report questionnaires were administered, including: - Functional Assessment of Cancer Therapy – Prostate Version (FACTP), assessing Health-related QoL in terms of physical well-being, social well-being (SWB), emotional well-being (EWB), functional wellbeing (FWB) and wellbeing related to prostate cancer symptoms (PCS); scores > 3 identify a very high level of wellbeing within the considered area. - Mini-Mental Adjustment to Cancer Scale (Mini-MAC), assessing style of adjustment to cancer in terms of fighting spirit (FS), anxious preoccupation (AP), helplessness/hopelessness (HH), fatalism (FA) and avoidance (AV); scores > 2 imply a presence of the disease adjustment style considered. Results: Both pts who chose RT and AS pts reported very high levels of PWB (92% and 97% respectively), EWB (66% and 54% respectively) and PCS (66% and 76% respectively). A few pts achieved very high FWB (18% and 27% respectively). RT and AS pts reported presence of FS (87% in both groups) and FA (66% and 61% respectively), no disease-related AP (76% and 72% respectively), no sense of HH (92% and 93% respectively) and no AV behaviour (71% and 62% respectively). The statistical differences between the mean scores were evaluated with Student t-test. Results showed that SWB (p=0.0001) and PCS (p=0.027) were statistically lower in the RT group (SWB: mean=2.57+/-0.84; PCS: mean=3.07+/-0.48) than in AS (SWB: mean=3.08+/-0.64; PCS: mean=3.25+/-0.39). These differences between the compared groups didn’t reach clinical relevance, defined as the minimal important difference of half the standard deviation. Conclusions: HRQoL was very high in both groups of pts, except for FWB. The low level of FWB (i.e. limitations in the performance of social roles or activities) before starting therapies is counterintuitive and subscale validity should be further investigated on a larger sample. Adjustment to cancer was positive in both RT and AS pts. To conclude, PCa pts who choose RT report a good level of QoL, comparable with that of pts undergoing AS. Further work is being done to evaluate HRQoL after RT treatment Acknowledgements to I. Monzino and ProADAMO Foundations for founding psychological support for PCa patients.
ESTRO 31
PO-0673 ACTIVE SURVEILLANCE FOR LOW-RISK PROSTATE CANCER: PRACTICE AMONGST UROLOGISTS FROM FOUR EUROPEAN COUNTRIES A. Azmi1, R. Dillon2, S. Borghesi3, M. Dunne4, R. Power5, R. Marignol2, B.D.P. O'Neill1 1 St. Luke's Radiation Oncology Network, Department of Radiation Oncology, Dublin, Ireland Republic of 2 Trinity College Dublin, Division of Radiation Therapy, Dublin, Ireland Republic of 3 Radiotherapy Unit, San Donato Hospital, Arezzo, Italy 4 St. Luke's Hospital, Clinical Trials Unit, Dublin, Ireland Republic of 5 Beaumont Hospital, Department of Urology, Dublin, Ireland Republic of Purpose/Objective: Active surveillance (AS) is a recognized treatment option for low-risk prostate cancer (PCa). The optimal AS strategy is undefined. We carried out a web-based survey to evaluate how AS is practiced amongst European Urologists. Materials and Methods: 2959 potential participants were identified via various European urological association databases and invited via email to complete an online survey about their practice of AS including eligibility criteria, follow-up protocols and triggers for intervention. Analyses were conducted on the four countries with the most responses. The Chi-square test was used to compare groups. Statistical analyses were carried out using SPSS version 18.0. Results: The countries with the most responses are Italy (n=49), the UK (n=42), the Netherlands (n=18) and France (n=15). 96% of respondents from these countries offer AS as a treatment option. 56% use an official protocol and 32% offer AS as part of a clinical trial. There is a significant association between country of practice and using an official AS protocol (p=0.044) and participating in a clinical trial (p=0.001). Urologists in the Netherlands were the most likely to use an official AS protocol (83%) and to offer AS within a clinical trial (67%). The Urologists are in relative agreement that a PSA ≤ 10ng/ml (74 to 100%) and Gleason score 3+3=6 (63 to 100%) are used as eligibility criteria. There is less agreement with respect to age, clinical stage and the percent or number of biopsy cores involved. There is a significant association between performing an MRI prior to enrolling patients in AS and country of practice (p<0.001), with Urologists in France (73%) and the UK (69%) being most likely to carry this out. Follow-up protocols vary both within each country and between the four countries. There is a significant association between country of practice and using symptomatic disease progression (p=0.012), >50% of any core involved (p=0.015) and >2 cores involved (p=0.002) on repeat biopsy as trigger factors for radical treatment. Urologists in France and Italy were most likely to use symptomatic disease progression and >50% of any core involved as trigger factors while Urologists in the UK were least likely to use >2 cores involved on repeat biopsy as a trigger for intervention. Conclusions: This survey highlights the wide variation in the practice of AS amongst European Urologists from four European countries. Further studies are required to determine the optimal AS strategy and Clinicians are encouraged to enrol their patients in clinical trials to enable an evidence-based guideline to be established. PO-0674 POST-OP PROSTATE RADIOTHERAPY: THE CASE OF THE MISSING TARGET, MYSTERY SOLVED J.M. Croke1, B. Nyri2, Y. Li1, L. Avruch3, E. Belanger4, C. Morash5, C. Kayser1, K. Malone1, S. Malone1 1 The Ottawa Hospital Cancer Centre, Radiation Oncology, Ottawa, Canada 2 The Ottawa Hospital Cancer Centre, Medical Physics, Ottawa, Canada 3 The Ottawa Hospital, Diagnostic Imaging, Ottawa, Canada 4 The Ottawa Hospital, Anatomical Pathology, Ottawa, Canada 5 The Ottawa Hospital, Urology, Ottawa, Canada Purpose/Objective: Postoperative radiotherapy (RT) increases survival in high-risk (pT3, margin positive) prostate cancer (PCa) patients (pts). Despite the benefit of adjuvant RT approximately 50% of pts relapse in long-term follow-up, with the primary site of failure being local (SWOG 8794). The EORTC and RTOG have published consensus guidelines to delineate post-op CTV for PCa. The study objectives were: 1. To compare CTV EORTC and CTV RTOG to preoperative MRI defined prostate and gross tumour. 2. To create a modified CTV (CTV TOH) that incorporates pre-op MRI.