Active surveillance in young prostate cancer patients : From the PRIAS-JAPAN study

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1 MP Active surveillance in young prostate cancer patients : From the PRIAS-JAPAN study Takuma Kato, Mikio Sugimoto, Yoshiyuki Kakehi, PRIAS-JAPAN Study Group Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan Japan is participating in the Prostate cancer Research International: Active Surveillance (PRIAS) study as PRIAS-JAPAN since 200. We assessed the state of younger AS patients from the analysis Japanese cohort(prias-japan) The inclusion criteria for the PRIAS study Clinical stage Tc/T2 PSA 0 ng/ml, PSA density < 0.2 ng/ml Positive biopsy cores one or two cores Gleason score 6 The follow-up protocol for the PRIAS study Year Month PSA DRE PBx Pathological reclassification is defined as the deviation of pathological findings on re-biopsy from the inclusion criteria. Patients are recommended active treatment if the PSA doubling time (PSADT) is <3 years (until December 204) or if reclassification is comfirmed on re-biopsy. Since 205, PSADT has become a trigger for extra yearly re-biopsy, and patients are not recommended active treatment because of short PSADT (<3 years). In this analysis, we defined re-biopsy at -year as st re-biopsy and at 4-year biopsy including extra biopsy as 2nd re-biopsy. We compared the clinical outcome and pathological result of rebiopsy between the group of less than 60 years old (young group) and the groups of over 60 years old or more (aged group). Until September 207, 76 patients were enrolled from 37 institutions. In this population, 96 were in young group at enrollment Age PSA (ng/ml) PSA density (ng/ml cm3 ) Prostate volume( cm3 ) T classification Number of biopsy cores Cancer positive cores Cancer detecting rate (positive cores/total cores) GS Baseline characteristics of the study population Young group (n=96) 45~59 (56) 0.9~9.75 (4.9) 0.03~0.9 (0.6) 9.~67.7 (33.0) Aged group (n=67) 60~7 (69) 0.75~ ~0.99 (0.4) 3.6~0.5 (3.75) Tc T ~22 0~42 core cores ~ ~ p value 0.0 * * <0.00 * 0.06 ** 0. * 0.7 *** 0.52 * *Unpaired T test **Fisher's exact test ***Chi-squared test Table3. The details of the following therapy Young group (n=24) Aged group (n=92) prostatectomy 54% 36% EBRT 2% 20% Radiation LDR 6% 7% therapy Hormone therapy heavy particles irradiation 0.5% LH-RH 4% 0% AA.5% orchiectomy 0.5% watchful waiting 4% % unknown 3% There is a not significant difference between both group in AS remaining rate. Younger patients tend to avoid re-biopsy but to choose surgery as a definitive therapy. COI: nothing to disclose Table2. Results of st and 2 nd repeat biopsy Figure. Active surveillance remaining rate PSA (ng/ml) T classification Number of biopsy core Number of cancer positive cores Cancer detecting rate (positive cores/total cores) Reclassification Non-reclassification Non-reclassification (GS3+4 for the patient more than 70years) No cancer Young group (n=49).2~7 st repeat biopsy 2 nd repeat biopsy Aged group (n=447) 0.4~25.3 (5.7) P value 0.74* young group aged group Young group (n=0).7~6. (5.) Aged group (n=93).~25. (7.) Tc ** T2 3 6 unknown 2 7~22 0~0.57 (0.05) (6.3%) (36.7%) 23 (46.9%) ~25 0~ 0~ (27.7%) 57 (35%) 7 (3.%) 49 (33.3%) 0.7* 0.24*** 0.2* 0~22 0~4 0~0.3 (0.03) 2 (20%) 5 (50%) 3 (30%) ~25 0~0.4 (0.03) 2 (22.5%) (.6%) P value 0.54* 0.52** 0.23* 0.4*** 0.75* *Unpaired T test **Fisher's exact test ***Chi-squared test yr

2 The inclusion criteria for the PRIAS study clinical stage PSA PSA density positive biopsy cores Tc/T2 0 ng/ml, < 0.2 ng/ml one or two cores Gleason score 6 Year Month PSA DRE PBx

3 60 歳未満 (n=96) 60 歳以上 (n=67) p 値 年齢 45~59 歳 60~7 歳 (56 歳 ) (69 歳 ) PSA(ng/ml) 0.9~ ~ * (4.9) PSA density(ng/ml/ cm3 ) 0.03~ ~ * (0.6) (0.4) 前立腺体積 ( cm3 ) 9.~ ~0.5 <0.00 * (33.0) (3.75) T 分類 Tc T ** 生検コア数 ( 本 ) ~22 0~42 0. * がん陽性コア数 ( 本 ) 本 本 *** がん陽性率 (positive cores/total cores) 0.04~ ~ * GS *:unpaired T test **Fischer exactry rate ***Χ2 検定

4 Young group(n=96) Aged group(n=67) p value age 45~59 60~7 (56) (69) PSA (ng/ml) 0.9~ ~ * (4.9) PSA density (ng/ml cm3 ) 0.03~ ~ * (0.6) (0.4) Prostate volume( cm3 ) 9.~ ~0.5 <0.00 * (33.0) (3.75) T classification Tc T ** Biopsy cores ~22 0~42 0. * Cancer positive cores core cores *** Cancer detecting rate (positive cores/total cores) 0.04~ ~ * GS *:unpaired T test **Fischer exactry rate ***Χ2 検定

5 yr young group aged group

6 年 若年群.00 高齢群

7 prostatectomy (RP+LRP+RALP) EBRT LDR 重粒子線 HTx watchful waiting unknown LH-RH AA orchiect omy Young group (n=24) 3 (54.%) 5 (20.%) 4 (6.6%) (4.%) (4.%) Aged group (n=92) 69 (35.9%) 3 (9.7%) (6.6%) (0.5%) 20 (0.4%) 3 (.5%) (0.5%) 22 (.4%) 6 (3.%)

8 60 歳未満 (n=24) 60 歳以上 (n=92) 前立腺全摘 (RP+LRP+RALP) EBRT LDR 重粒子線 HTx watchful waiting 不明 LH-RH AA 除睾術 3 (54.%) 5 (20.%) 4 (6.6%) (4.%) (4.%) 69 (35.9%) 3 (9.7%) (6.6%) (0.5%) 20 (0.4%) 3 (.5%) (0.5%) 22 (.4%) 6 (3.%)

9 再生検の結果 回目の生検の結果 2 回目の生検の結果 60 歳未満 (n=49) 60 歳以上 (n=447) p 値 60 歳未満 (n=0) 60 歳以上 (n=93) p 値 PSA(ng/ml).2~7 0.4~25.3.7~6..~ (5.7) (5.) (7.) T 分類 Tc T 不明 2 生検コア数 ( 本 ) 7~22 ~ ~22 ~ がん陽性コア数 ( 本 ) 0~ ~4 0.4 がん陽性率 (positive cores/total cores) 0~0.57 (0.05) 0~ ~0.3 (0.03) 0~0.4 (0.03) 0.75 reclassification (6.3%) 24 (27.7%) 2 (20%) 2 (22.5%) non-reclassification (36.7%) 57 (35%) 5 (50%) non-reclassification 7 (70 歳以上の GS3+4) (3.%) (.6%) no cancer 23 (46.9%) 49 (33.3%) 3 (30%)

10 再生検の結果 st repeat biopsy 2 nd repeat biopsy Young group (n=49) Aged group (n=447) P value Young group (n=0) Aged group (n=93) P value PSA(ng/ml).2~7 0.4~25.3.7~6..~ * (5.7) (5.) (7.) Tclassification Tc ** T * 0.52** 不明 2 Number of biopsy core 7~22 ~25 0.7* 0~22 ~ * Number of cancer positive cores 0~ 0.24*** 0~4 0.4*** Cancer detecting rate (positive cores/total cores) 0~0.57 (0.05) 0~ * 0~0.3 (0.03) 0~0.4 (0.03) 0.75* reclassification (6.3%) 24 (27.7%) 2 (20%) 2 (22.5%) non-reclassification (36.7%) 57 (35%) 5 (50%) non-reclassification (GS3+4 for the patient more than 70years) 7 (3.%) (.6%) no cancer 23 (46.9%) 49 (33.3%) 3 (30%)

11 Young group(n=96) Aged group(n=67) p value age 45~59 60~7 (56) (69) PSA (ng/ml) 0.9~ ~ * (4.9) PSA density (ng/ml cm3 ) 0.03~ ~ * (0.6) (0.4) Prostate volume( cm3 ) 9.~ ~0.5 <0.00 * (33.0) (3.75) T classification Tc T ** Biopsy cores ~22 0~42 0. * Cancer positive cores Cancer detecting rate core cores *** (positive cores/total 0.04~ ~ * cores) GS *:unpaired T test **Fischer exactry rate ***Χ2 検定