No abstract

BackgroundFollowing radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22–47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy.AimTo reduce the risk of bladder cancer recurrence by a single intravesical instillation of Mitomycin immediately (within 3 h) before radical nephro-ureterectomy or partial ureterectomy.MethodsAdult patients (age ≥ 18 years) with a (suspicion of a) urothelial carcinoma of the UUT undergoing radical nephro-ureterectomy or partial ureterectomy will be eligible and will receive a single intravesical instillation of Mitomycin within 3 h before surgery. In total, 170 patients will be included in this prospective, observational study. Follow-up will be according to current guidelines.ResultsThe primary endpoint is the bladder cancer recurrence rate up to two years after surgery. Secondary endpoints are: a) the compliance rate; b) oncological outcome; c) possible side-effects; d) the quality of life; e) the calculation of costs of a single neoadjuvant instillation with Mitomycin and f) molecular characterization of UUT tumors and intravesical recurrences.ConclusionsA single intravesical instillation of Mitomycin before radical nephro-ureterectomy or partial ureterectomy may reduce the risk of a bladder recurrence in patients treated for UUT urothelial carcinoma and will circumvent the disadvantages of current therapy.

INTRODUCTION AND OBJECTIVES:The value of targeted prostate biopsy via MRI guidance has been established for men undergoing repeat biopsy. In men undergoing first biopsy, we conducted a prospective trial, using each man as his own control, to test the value of targeted biopsy (TBx) (cognitive and MR/US fusion) vs TRUS-guided standard 12-core biopsy (SBx) (PAIREDCAP Trial).METHODS: Study was IRB-approved and NCI-funded. A powered sample of 226 biopsy-naive men with elevated PSA underwent 3T multiparametric MRI (mpMRI). Mean age¼65 yrs (SD 6.8) and median PSA¼5.9 ng/mL ). Men with PI-RADS 3 lesions (n¼176) all underwent, in this order at one sitting, (1) SBx, (2) cognitive targeted biopsy directed by in-room radiologist, and (3) MR/US fusion targeted biopsy. Men with PI-RADS < 3 (n¼50) underwent SBx only. Primary outcome was detection of Gleason score (GS) 3+4 prostate cancer (cancer detection rate, CDR).RESULTS: 176 men had PI-RADS 3 (Fig 1). Overall CDR in these men was 69% (121/176); 7% (12/176) were detected only by a TBx. CDR increased with PI-RADS score; concordant CDR of SBx and TBx were directly related to PI-RADS score (Fig 2). TBx alone contributed 17% of positive biopsies for PI-RADS 3 lesions but only 8% for PI-RADS 5 lesions. PSA density (PSAD) was also predictive of overall CDR: 87% for PSAD 0.15 ng/ml/cc and 50% for PSAD <0.15 ng/ml/cc (p<0.01). Among men with PI-RADS 4 lesions, CDR increased by 50% when PSAD exceeded 0.15 (27/30 if PSAD 0.15; 16/28 if PSAD <0.15; p<0.01). CDR was inversely related to prostate volume but not related to MRI region of interest (ROI) diameter. CDR by MR/US fusion was higher than the cognitive method irrespective of all other variables (p<0.01). In the 50 men with PI-RADS < 3 (no ROI to target), CDR was 16% (8/50) by standard 12-core biopsy.CONCLUSIONS: In biopsy-naive men, TBx provides only marginal benefit over SBx in CaP detection. The combination led to the highest CDR. PI-RADS score and PSAD are important predictors of clinically-significant CaP.

No abstract

No abstract

No abstract

No abstract

No abstract