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1972 PROSPECTIVE EVALUATION OF JAPANESE PATIENTS WHO UNDERGO ACTIVE SURVEILLANCE CLINICO-PATHOLOGICAL OUTCOMES AND QOL Mikio Sugimoto*, Yoshiyuki Kakehi, Hiroyuki Tsunemori, Miki-cho Kitagun Kagawa Pref., Japan; Haruhiko Fukuda, Tokyo, Japan; Taizou Shiraishi, Mie Pref., Japan; Toshiyuki Kamoto, Kyoto-city, Japan INTRODUCTION AND OBJECTIVES: This study was carried out to clarify outcomes of Japanese patients with low risk prostate cancer who underwent active surveillance (AS) as an initial treatment. Up-grading in re-biopsy or prostatectomy specimens was also investigated. Factors that influence on dropping out from AS program were also analyzed. METHODS: 134 patients meeting the criteria 1) stage T1cN0M0, 2) age 50-80, 3) serum prostate specific antigen (PSA) <20 ng/ml, 4) one or two positive cores per 6-12 systematic biopsy cores, 5) Gleason score <6, and 6) cancer involvement in positive core <50% were enrolled in current study between January 2002 and December 2003. 117 actually chose AS, while 14 underwent radical prostatectomy (RP) as the initial treatment. A median observation period was 61 months. Patients undergoing AS were recommended to start treatment when PSADT assessed with all PSA measurements was <2 years. The patients who remained on AS for 1 year were recommended to undergo re-biopsy and those who did not fit the initial pathology criteria were also recommended to start aggressive treatment. The patient-reported health-related quality of life (HRQOL) was assessed at the time of registration and 1 year later. General HRQOL was evaluated with the Japanese version SF-36. RESULTS: Of the 117 patients who chose AS, 34 remained on AS for maximal observation of 78 months with 5-year actuarial ASremaining rate being 41.4%. The reasons for leaving AS in 70 patients were as follow: PSADT<2 years in 23, pathological progression in 16 , change in T-stage in 4 and difficult voiding due to concomitant BPH in 11. 16 patients chose immediate treatment, 14 (group A) out of 16 opted for RP. Twenty eight patients (group B) out of 117 underwent RP in the course of AS program. Total of 42 patients who underwent RP (group A and group B), 21 were upgraded to Gleason score seven or more (3+4: 17, 4+3: 1, 4+4: 2, 4+5: 1). Capsular invasion were found in 7 patients, but there was no lymphatic, vascular and seminal vesicle invasion. Life threatening cancer defined as >pT3 or >8 GS were found 2 out of 14 in group A and 8 out of 28 in group B.SF-36 scores at 1 year after AS were not statistically different from the baseline scores. CONCLUSIONS: Lower urinary tract symptoms are one of the negligible reasons for leaving AS. And in pathological findings, however, there is the possibility of dedifferentiation, it was suggested that the issue of underestimation in initial prostate biopsy was considerable problem in this study. A more strict selection criterion should be warranted. Source of Funding: None

1973 RESULTS OF LOW THRESHOLD TO BIOPSY FOLLOWING HIGH INTENSITY FOCUSED ULTRASOUND FOR LOCALISED PROSTATE CANCER Richard L Haddad*, Henry H Woo, Sydney, Australia INTRODUCTION AND OBJECTIVES: High intensity focused ultrasound (HIFU) has been increasingly used to treat localised prostate cancer. Results to date seem to suggest that HIFU results are not disimilar to established treatments for localised prostate cancer. Success of HIFU is largely based upon biochemical PSA results rather than biopsy proven persistence of disease. The objective of this study was to evaluate the impact of using a low threshold to biopsy to gauge success of HIFU. METHODS: Data was prospectively collected between 2006 2008 representing the results of a single surgeon experience, performed in conjunction with an experienced technical team which in itself had performed over 100 cases. Following HIFU, PSA was monitored at 3 monthy intervals. Biochemical PSA failure was defined as two consecutive PSA rises, or a PSA q0.5 ng/mL. Post-HIFU biopsies were undertaken using a 12 core technique under a local anaesthetic prostate block.

Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009

RESULTS: Eleven patients underwent HIFU with 10 patients as a primary treatment modality and for one patient as a second line therapy after failed external beam radiotherapy. Mean patient age was 68 years (range, 48-77 years). Mean PSA at diagnosis was 7.7 ng/mL (range, 5.7-10.8 ng/mL). Three had D’Amico low risk disease, while 8 had intermediate risk disease. Mean prostate volume was 28 cc (range, 22-37 cc). Mean length of follow up was 16 months (range, 7-26 months). Nine patients (82%) had biochemical failure and underwent post-HIFU biopsy and all had biopsy-proven residual disease. The mean time to post-HIFU prostate biopsy (9 patients) was 11.6 months (range, 5-20 months). Three patients went onto salvage radical retropubic prostatectomy (RRP). Two had more HIFU. Three elected to have management by watchful waiting. One was lost to follow up. There was no major morbidity or mortality in either primary or subsequent treatment. CONCLUSIONS: A low threshold to re-biopsy patients treated by HIFU reveals a high local failure rate of 82%. This brings into question its oncological efficacy, especially when the patient group is typical for those in whom conventional options such as radical prostatectomy would have been appropriate. High thresholds to perform post-HIFU biopsy are likely to be over estimating the true efficacy of HIFU as a treatment for localised prostate cancer. To base the success of HIFU on biochemical outcomes alone should be reconsidered. Source of Funding: None

1974 2 YEARS BIOCHEMICAL FAILURE FREE SURVIVAL FOLLOWING HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) FOR LOCALIZED PROSTATE CANCER: PROSPECTIVE COHORT SINGLE CENTER STUDY OF 196 PATIENTS Jehonathan H Pinthus*, Forough Farrokhyar, Hamilton, ONCanada; Magdy M Hassouna, Toronto, ONCanada; Edward Woods, Scarborough, ONCanada; William L Orovan, Hamilton, ON, Canada INTRODUCTION AND OBJECTIVES: HIFU is an emerging ablative modality for the treatment of localized prostate cancer with limited reports on oncological outcome. We prospectively analyzed our 2 years results. METHODS: 253 consecutive patients (age: 64+8) were treated with a planed single session of HIFU using the Ablatherm integrated imaging model system between January 2006 and June 2008. Patients were followed (median: 12; range 3-24 months) with PSA measurement every 3 months. Patients who received prior radiation or hormonal therapy (n=25) and patient for whom at least 2 consecutive PSA measurements were not available (n=32) were excluded, leaving a total of 196 patients for analysis. Mean Pre-treatment PSA was 6.9+3.3. Biopsy Gleason scores at diagnosis (median 9 cores) were 5, 6, 3+4, 4+3 in 1, 91, 66 and 38 patients, respectively. Biochemical failure (BCF) were analyzed by Stephenson (PSA >0.4ng/ml and rising), modified ASTRO (2 consecutive rise above nadir), Phoenix (nadir+2ng/ml) and Stuttgart (nadir+1.2ng/ml) definitions. RESULTS: Of 196 patients, 75 had low and 121 had intermediate disease based on D’Amico risk stratification. Mean absolute PSA nadir was 0.28+0.53 ng/ml. It was achieved in median time of 3 months and remained unchanged in 70% of the patients throughout the follow-up. Overall 2 years BCF free rates were 86 %( 81-91%), 96% (91-99%), 81 %( 70-91%) and 70 %( 62-78%) according to the modified ASTRO, Phoenix, Stuttgart and Stephenson definitions, respectively; with no significant differences between risk groups. The predictors of BCF were absolute nadir [HR: 3.0 (2.3-3.8)] and pre-treatment PSA [HR: 1.1 (1.0-1.2)]. Overall and cancer related survival were 99.5% and 100%, respectively. 13% developed strictures and were treated successfully with trans-urethral visual uretherotomy. CONCLUSIONS: This is the only study to date that analyzed post HIFU BCF free rates according to post radical prostatectomy definition of BCF. BCF usually occur in the first year and plateau thereafter. Short term results by all BCF definitions are promising with similar results for patients with low and intermediate risk. Pre-HIFU PSA and post-HIFU PSA nadir levels are predictors for BCF. Source of Funding: None