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242 Background: Prostate health index (phi) using -2proPSA (p2PSA), which is a precursor of PSA, has been reported to be useful as a marker for predicting the presence of cancer in the gray zone with a PSA value of 4-10 ng/ml. There is no detailed report on the biology of p2PSA in castration resistant prostate cancer (CRPC) patients and it is unknown. We retrospectively investigated the biology of p2PSA and its usefulness as a marker using CRPC patient's samples. Methods: The study was performed using samples from a prospective study of CRPC patients treated with enzalutamide. We examined 98 pre-enzalutamide treatment serum samples that can measure p2PSA. The samples were collectively measured by Beckman Coulter (Tokyo, Japan). We also examined the correlation between the measurement results of p2PSA and the prognosis of phi and CRPC patients calculated accordingly. This study was approved by the IRB of Gunma University Hospital (IRB 2021-092, 1983). Results: The study population of 98 patients had a median age of 73 years. The median PSA before administration of enzalutamide was 23.8 ng/ml, the median p2PSA was 208.8 pg/ml, and the median phi was 188.0. The median values of each parameter were divided into two groups, and the PSA progression free survival (PSA-PFS) and overall survival (OS) rate were compared by the Kaplan-Meier method. In the study of PSA-PFS, PSA, p2PSA, and phi could not be significant markers. In the OS study, the median OS of the PSA low group was NYR (not yet reached), the high group was 26.8 months, the p2PSA low group was NYR, the high group was 26.8 months, the phi low group was NYR, and the high group was 26.8 months. The OS was significantly better in the low- value group for each parameter (p-values 0.024, 0.034, 0.018, respectively). Conclusions: The biology of p2PSA in CRPC patients has been clarified. Although we couldn't find a clear advantage over PSA, we would like to add a study based on the data of this study.

79 Background: Enzalutamide (ENZ) is used to treat patients with castration-resistant prostate cancer (CRPC). Quality of life (QOL) during ENZ treatment for CRPC patients is very important, but the markers that predict QOL are unknown. We investigated the relationship between serum testosterone (T) levels before ENZ and QOL changes in CRPC patients. Methods: We conducted a prospective study from 2014 to 2018 at Gunma University Hospital and related facilities. We analyzed 95 patients who were able to evaluate QOL by FACT-P before, 4 weeks, and 12 weeks after ENZ administration. We measured serum T levels using liquid chromatography-tandem mass spectrometry (LC-MS/MS). This study was approved by the institutional review board of Gunma University Hospital (No.1177). Results: The study population of 95 patients had a median age of 72 years and median PSA of 21.6 ng/ml. The median overall survival from the time of ENZ administration in 95 cases was 26.8 months. The median serum T levels before ENZ treatment was 50.0 pg/ml. The mean total FACT-P score before ENZ administration, 4 weeks and 12 weeks later were 95.8, 91.7, and 90.1, respectively. 95 patients were divided into two groups, a high T levels (T-High) group and a low T (Low-T) group, and changes in FACT-P were examined. The mean FCAT-P values in the High-T and Low-T groups were 98.5 and 84.6 after 4 weeks and 96.4 and 82.2 after 12 weeks, which were significantly higher in the High-T group (p < 0.05, respectively). In the Low-T group, the mean FACT-P value after 12 weeks was significantly lower than that before administration (p < 0.05). Conclusions: It was suggested that the serum T levels of CRPC patients before ENZ treatment may be useful for predicting marker of QOL changes after ENZ treatment.

236 Background: We mainly perform Robotic-Assisted laparoscopic Radical Prostatectomy (RARP) and Carbon Ion Radiotherapy (CIRT) as curative treatment for prostate cancer. Several factors such as cancer control and quality of life after treatment are considered to be important, but there are few reports comparing sexual function changes before and after treatment between RARP and CIRT. We performed retrospective study comparing the evaluation of sexual function after RARP and CIRT cases using the propensity score matching method. Methods: 127 patients treated by RARP from 2014 to 2018 and 190 patients treated by CIRT monotherapy from 2010 to 2019 were evaluated. We evaluated Expanded Prostate Cancer Index Composite (EPIC) score before and after treatment. The EPIC was compared before, 12 months, and 24 months after treatment. Propensity score matching was performed using the age at treatment, PSA value, T stage, and pretreatment EPIC comprehensive score of sexual function as covariates. A cohort of 101 patients in each group was prepared and examined. This study was approved by the Institutional Review Board of Gunma University Hospital (No. IRB2020-050, 1839). Results: The mean ± standard deviation of each of the RARP and CIRT groups were age; 65.1 ± 5.9, 65.3 ± 6.5 years, PSA value; 6.31 ± 2.07, 6.34 ± 2.46 ng/ ml, pretreatment EPIC sexual function overall score; 46.4 ± 15.6, 48.2 ± 16.2. In both groups, T1N0M0 was 16%, T2N0M0 was 83%, and T3N0M0 was 1%. The total EPIC sexual function scores before, 12 months, and 24 months after treatment were 46.4, 27.9, 28.2 in the RARP group, and 48.2, 41.4, 41.6 in the CIRT group, respectively. In both groups, there was a significant decrease in score after 12 months and 24 months compared to before treatment (p < 0.05). At 12 and 24 months, the total EPIC sexual function score in the CIRT group was significantly higher than RARP group (p < 0.001). Conclusions: In prostate cancer cases adjusted by propensity score matching, the decrease in EPIC sexual function score was significantly smaller in the CIRT group than RARP group. The results of this study seemed to be useful information for decision making with patients.

146 Background: Enzalutamide (ENZ) is commonly used to treat patients with castration resistant prostate cancer (CRPC). However, the kinetics of serum androgen levels before and after ENZ treatment are unknown. We elucidated the kinetics of serum androgens and explored the possibility of identifying a useful marker for predicting the effects of ENZ. Methods: We conducted a prospective study from 2014 to 2018 at Gunma University Hospital and related facilities. 104 CRPC patients treated with ENZ were analyzed. We investigated the PSA reduction rate (50%, 90%), PSA-progression-free survival (PFS), and overall survival (OS) after administration. To measure levels of androgens accurately we measured serum androgen levels using LC-MS/MS. OS and PSA-PFS were assessed according to the PCWG 2 criteria. This study was approved by the Institutional Review Board of Gunma University Hospital (No. 1177). Results: The 50% and 90% PSA decline rates were 62.5% and 25.0%, respectively. Median serum testosterone (T), dihydrotestosterone (DHT), androstenedione (A-dione), and dehydroepiandrosterone-sulfate levels were 49.0, 5.8, 222.2, and 326.3 pg/ml, respectively. Mean serum levels of T, DHT, and A-dione increased significantly 12 and 24 weeks after compared to before treatment (p < 0.05). We performed a multivariate analysis using a Cox regression to predict OS and PSA-PFS. ECOG PS (0 vs. 1–2), hemoglobin (Hb ≥ 12.5 vs. < 12.5 g/dL), albumin (≥ 3.9 vs. < 3.9 g/dL), visceral metastasis (no vs. yes), EOD (0–2 vs. 3–4), docetaxel treatment (no vs. yes), and DHT level (≥11.25 vs. < 11.25 pg/mL, 11.25 was third quartile) were significant predictors of OS (p < 0.05). Hb (≥12.5 vs. < 12.5 g/dL), docetaxel treatment (no vs. yes), and level of DHT (≥ 5.9 vs. < 5.9 pg/mL) were significant predictors of PSA-PFS (p < 0.05). As a result of the binomial logistic analysis of the predictors of fatigue and decreased appetite, the presence of visceral metastasis (yes) and low DHT (

292 Background: Recent studies have shown that an early PSA response to AR-targeting agents in mCRPC is associated with a better prognosis. We analyzed the early PSA response to enzalutamide (ENZ) by measuring the PSA doubling time (PSADT) and PSA Velocity while monitoring oncologic outcomes and survival in Japanese patients. Methods: A total of 241 patients with mCRPC treated with ENZ were analyzed. Patients’ median age is 75±7.9 (range 53-93). The patients pre-docetaxel settings were 171 cases (71 %), post-docetaxel settings were 70 cases (29 %). The PSA-PFS and OS were assessed according to PCWG2 criteria. This study was approved by the institutional review board of Gunma University Hospital (No.1595). Results: A case where PSA did not decline at all was defined as Primary Resistance (PR). A case in which PSA once declined after treatment but then progressed was defined as Acquired Resistance (AR). Those in which PSA remained low after treatment were defined as Good Response (GR). We observed 77 PR cases (31.9 %), 125 AR cases (51.9 %) and 39 GR cases (16.2 %).PSA-PFS and OS pre-docetaxel were significantly increased as compared to patients’ post-docetaxcel (PSA-PFS; 47.0 wks vs. 13.4 wks p < 0.001, OS; Not Yet Reached vs. 80.7 wks p < 0.001). Multivariate analysis of prognostic factors, including the PSA response at 4 weeks, was performed using a Cox regression analysis. The PS (0 or 1-2), Hb (≧11.4 or < 11.4), time to CRPC(≧12 m or < 12 m), docetaxel treatment history (none or done) and a PSA decrease of 50% at 4 weeks were all significant factors for the prediction of OS (all variables, p < 0.05). In cases of acquired resistance (n = 125), a multivariate analysis using PSA kinetics factors such as PSADT and PSA Velocity (ng/mL/month) at PSA progression, Hb, time to CRPC(≧12 m or < 12 m), PSADT (≧2 months or < 2 months) and PSA Velocity ( < 20 ng/mL/month or≧20 ng/mL/month), were all factors predicting OS following PSA progression (p < 0.05). Conclusions: Our study has demonstrated that PSA dynamics after ENZ administration may be a useful prognostication factor for mCRPC patients.