[Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial]. / Instillation préopératoire immédiate (IPOI) de mitomycine C comparée à l'instillation postopératoire précoce (IPOP) dans les tumeurs de la vessie. Étude de phase II randomisée.

OBJECTIVE: A single immediate instillation of mitomycin C is recommended after a complete transurethral resection of the bladder (TURB) in low- and intermediate-risk patients with NMIBC. Actually, post-TURB instillation is seldom used due to logistical difficulties and surgical contraindications. Our aim was to compare patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of mitomycin C. METHODS: We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score. RESULTS: Among 35 eligible participants, 20 were randomly assigned in the pre-TURB instillation group and 15 in the post-TURB instillation group. Follow-up was comparable: 12,3±1,6 months in the SI group and 10,2±4,5 months in the pre-TURB instillation group. In the post-TURB instillation group, 2 patients didn't have any instillation. We did not identify significant differences in disease-free interval. Tolerance at 1 month after TURB was similar in both groups. CONCLUSION: Tolerance and efficacy were not significantly different. As expected, logisitics were easier for the health providers in the pre-TURB group where all patients had their instillation conversely to the post-TURB group. These results suggest that the advantages of a single immediate pre-TURB instillation warrant further evaluation of this strategy in a phase III randomized trial.

[Estimating minimum period of time to perform prostate MRI after prostate biopsy: Clinical and histological bleeding risk factors; from a prospective study]. / Évaluation prospective du délai minimum de réalisation de l'IRM prostatique après une biopsie de prostate : facteurs prédictifs cliniques et anatomopathologiques de remaniements hémorragiques.

A minimum delay of 4 to 6 weeks between biopsy and multiparametric prostatic MRI (mpMRI) is admitted due to post-biopsy hemorrhage that can impact MRI reading without strong scientific evidence. The objective of the study was to evaluate the best period between prostate biopsy and 3Tesla mpMRI and searching for predictive factors of intraprostatic blood. METHOD: A prostate biopsy followed by a 4-week prostate MRI (MRIp M1) was performed. In case of hemorrhage, MRI was rescheduled at 8 and 12 weeks (M2/M3). We analyzed the persistant bleeding to identify risk factors: anticoagulant/antiaggregant, post-biopsy side effects, histological criteria. RESULTS: In this prospective, single-center study, we included 40 patients followed for suspected prostate cancer between December 2014 and March 2016. At the MRIpM1, blood was found for 97.5 % of the patients. The rates were 90.9 % and 88.9 % respectively at the M2 and M3 mpMRI. Compared to initial blood volume on MRIpM1, a significant decrease in blood volume was observed between M1 and M2 (55 %; P=0.0091). We showed a 75 % decrease between M1 and M3 (P=0.0003). Low urinary tract symptoms (LUTS) suggesting urinary infection at 4 weeks were significantly correlated with blood volume on MRIpM1 (P=0.0063). The blood volume was higher in case of unconformity between biopsy and mpMRI results for detection of significant tumors (11.3 vs. 2.3; P=0.0051). CONCLUSIONS: A minimum of 8-week biopsy and mpMRI period would limit post-biopsy hemorrhage, predicted by LUTS suggesting urinary infection. A delay of 12 weeks would be optimal without delaying the management of the patient. LEVEL OF EVIDENCE: 4.

[The role of a single PCA3 test before a first negative prostate biopsy: 5-year follow-up]. / Intérêt du test PCA3 avant une première série de biopsies prostatiques négatives : 5 ans de suivi.

PURPOSE: We report a 5-year follow-up of a cohort of patients who underwent a first prostate biopsy following a prostate cancer antigen 3 (PCA3) test. MATERIAL AND METHODS: We reviewed consecutive patients who had in 2008 a single urinary PCA3 test using the Gen-Probe® assay before a first prostate biopsy for a prostate-specific antigen (PSA) between 3 and 20ng/mL and/or a suspicious digital rectal examination. PCA3 performances were analyzed in 2008 and then in 2013 after taking into account the results of repeat biopsies. RESULTS: At initial biopsy in 2008, among the 125 patients study cohort, prostate cancer was diagnosed in 47 patients (37.6%). Abnormal digital rectal exam, PSA density, prostate volume and PCA3 score were significantly associated with prostate cancer diagnosis. PCA3 area under the curve of the receiver operating curve was 0.67 [95%CI: 0.57-0.76] with an optimal threshold of PCA3 in this sample of 24 units. During the 5-year follow-up, among the 78 patients with a negative prostate biopsy in 2008, 23 (29.5%) had a repeat prostate biopsy of whom 14 were diagnosed with prostate cancer. PCA3 score measured in 2008 was associated with prostate cancer diagnosis (P=0.002). All 9 patients with a negative repeat prostate biopsy had a PCA3 score below the cut-off while this was the case in only 2 patients among the 14 with a positive repeat prostate biopsy. CONCLUSIONS: The results of a single PCA3 test before a first prostate biopsy seems to be a useful aid in deciding whether to perform a repeat biopsy. LEVEL OF EVIDENCE: 4.