transurethral resection (TUR) and additional adjuvant instillation in in- termediate risk non-muscle invasive bladder cancer (NMIBC) to reduce the risk of recurrence. Pirarubicin (THP), an anthracycline analogue, is widely used reagent for intravesical instillation chemotherapy. Several studies have showed that THP can rapidly penetrate tumor tissue after intravesical instillation. Therefore long instillation time (e.g. 120 min) may not be required for its prophylactic effect against recurrence since it may reduce the risk of adverse events such as cystitis and hematuria without compromising its efficacy. However, there is no high level evi- dence regarding optimized intravesical THP instillation time in terms of both toxicity and efficacy. METHODS: This randomized, prospective, open-label trial intended to enroll 160 pts with primary NMIBC with intermediate risk based on EORTC criteria. All pts received initial THP instillation within 24 hr after TUR and then intended to continue weekly repetitive THP instillation for a total of 9 treatments. Pts who seemed likely to be at intermediate risk were provisionally registered and then randomized into two groups with different intravesical THP retention times before TUR, (a) 30 min versus (b) 120 min. Follow-up period is 4 years. Primary endpoint is change from baseline in quality of life (e.g. OABSS and I- PSS), which will be evaluated prior to THP intravesical instillation. Secondary endpoint is recurrence-free survival. RESULTS: 126 pts were enrolled for provisional registration in this trial and randomized before TUR-B. After excluding pts due to the result of pathology by TUR-B such as benign disease, T1 G3 tumor and concomitance of CIS, 29 pts were assigned to group (a) (30 min), and 26 pts to group (b) (120 min). There is a trend that group (a) is less prone to increase in OABSS after 3rd instillation compared to group (b), which is not statistically significant. Log-rank test shows that there is no significant difference in recurrence-free survival between the groups during follow-up period (HR¼2.161, 95% C.I.: 0.4317-10.82, p¼0.3484). CONCLUSIONS: Shortening intravesical instillation period to 30 min has little effect on reducing the adverse effect of THP. However, it does not compromise the prophylactic effect on recurrence in inter- mediate risk NMIBC pts. Source of Funding: none MP13-06 CAN INTRAVESICAL ADMINISTRATION OF ANTIFIBRINOLYTIC AGENT POTENTIATE THE ACTION OF BACILLUS CALMETTE- GUERIN AFTER TRANSURETHRAL RESECTION OF NONeMUSCLE INVASIVE BLADDER CANCER?: MULTICENTER PROSPECTIVE RANDOMIZED CONTROLLED STUDY. Mohamed Soliman, Tanta, Egypt; Hussein Aldaqadossi*, Fayoum, Egypt; Ahmed El-Abd, Ahmed Abou- Ramadan, Mohamed El- Gharabawy, Abd-Elhamid El-Bahnasy, Tanta, Egypt; Mohamed Abd- Eltawab, Aswan, Egypt INTRODUCTION AND OBJECTIVES: Intravesical instillation of bacillus Calmette-Guerin (BCG) as an adjuvant therapy after transure- thral resection of nonemuscle invasive bladder cancer (TURBT) is considered to be the most effective treatment to prevent the recurrence and progression of the disease. The objective from this study is to evaluate the effect of intravesical instillation of antifibrinolytic agents with BCG in the management of superficial bladder tumors after TURBT. METHODS: This study was conducted on cohort of patients with primary nonemuscle invasive bladder cancer in whom the man- agement decision included TURBT with intravesical BCG instillation postoperatively. Patients were managed by TURBT, two weeks later; patients were randomized into two groups. Patients in group A sub- jected to intravesical instillation of BCG plus 2 gm of tranexamic acid while patients in group B were subjected to intravesical instillation of BCG alone. Prothrombin time was determined at 2 hours after instilla- tion. Complications in each group were reported. Follow-up cystoscopy was conducted three months after TURBT and then every three months during the first year followed by by annual cystoscopy in the following years. RESULTS: This study included 96 patients with mean age of 52.4  6.2. They were prospectively randomized into 2 groups (48 each). Follow-up ranged from 6 to 24 months (mean of 15.2  9 months). Four patients were lost to follow up (2 in each group). Another 15 patients (8 in group A and 7 in group B) developed serious BCG complications and excluded from the study. Postoperative prothrombin time showed no significant difference between both groups (P¼ 0.3). In the remaining 77 patients (38 patients in group A and 39 patients in group B), recurrence was reported in 3 out of 38 patients in group A (7.9%) and 11 out of 39 patients in group B (28%) with a statistically significant difference between both groups (P¼0.036). Progression was reported in only one patient in group A (2.6%) and 8 patients in group B (20.5%) with a statistically significant difference (P¼0.0286). CONCLUSIONS: Intravesical instillation of antifibrinolytic agents with BCG has improved the antitumor efficacy of BCG in the management of nonemuscle invasive bladder cancer following TURBT. Further studies including large number of cases are required to support these findings. Source of Funding: none MP13-07 IMPROVED EFFICACY OF ADJUVANT, SINGLE DOSE INTRAVESICAL APAZIQUONE BY TIMING POST-RESECTION IN TWO DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDIES IN NON-MUSCLE INVASIVE BLADDER CANCER Fred Witjes*, Nijmegen, Netherlands; Lawrence Karsh, Denver, CO; Mark Soloway, Aventura, FL; Gajanan Bhat, Guru Reddy, Allen Yang, Lee F. Allen, Irvine, CA; Neal Shore, Myrtle Beach, SC INTRODUCTION AND OBJECTIVES: Nonmuscle invasive bladder cancer (NMIBC) is characterized by frequent recurrences. Adjuvant intravesical chemotherapy administered within 24 hours post-transurethral resection (TURBT) has been shown to reduce recurrences. Apaziquone (APZ), a synthetic alkylating prodrug acti- vated in bladder cancer, was evaluated for immediate instillation post-TURBT in patients with low grade Ta (Grade 1 or 2) NMIBC in two studies (SPI-611; SPI-612). Because APZ can be inactivated by blood, an analysis was performed by time window of APZ dosing post-TURBT to determine the optimal timing; data on the 2 Year Recurrence Rate (2YRR) and Time to Recurrence (TTR) are re- ported here. METHODS: Both studies enrolled patients eligible for TURBT with presumed low grade Ta NMIBC, who were randomized (1:1) to APZ 4mg or placebo (PBO). An immediate (within 6 hours), single 40 mL intravesical instillation was given and retained for 1 hour. Eligibility included: central pathology confirmed low grade Ta tumors, no indi- vidual tumor >3.5 cm, and no >4 tumors (Target Pop). Patients were evaluated with cystoscopy every 3 months for 2 years. RESULTS: In total, 1614 patients (SPI-611- 802; SPI-612- 812) in the US, Canada and Poland were randomized (APZ- 808; PBO- 806) with 1146 patients (APZ- 577; PBO- 569) evaluable in the Target Pop. There were 456 patients treated in 30 min, 217 in 31-90 min, and 473 in >90 min post-TURBT with similar demographics across time window subgroups. Patients in the APZ 31-90 min sub- group demonstrated a significant absolute decrease of 21.8% in 2YRR (APZ- 28.2%; PBO- 50.0%; p¼0.0010), resulting in a relative reduc- tion of 43.6%. Improvements in other subgroups were not significant. Similarly, a longer TTR (HR¼0.48, p¼0.0096) was observed in the APZ 31-90 min subgroup. CONCLUSIONS: Adjuvant intravesical APZ administered 31 to 90 min post-TURBT significantly improved the 2YRR and TTR in these large phase 3, blinded, randomized placebo controlled studies. e136 THE JOURNAL OF UROLOGY â Vol. 195, No. 4S, Supplement, Friday, May 6, 2016