CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
Transurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal
 technique. Tumor fragmentation and cell spilling could be responsible for high recurrence
 rates. Circulating tumor cells (CTCs) have been shown to be a prognostic predictor in disease
 progression in transitional cell carcinoma. In the current study the investigators aim to
 quantify CTCs in purging fluid and blood for recurrent intermediate risk bladder cancer
 during surgery for two different methods: TURBT and Plasma-kinetic vaporization of bladder
 tumor (PKVBT). Also correlations for recurrence will be investigated for the two different
 surgical methods.
Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a
 standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000
 person-years for women. Amongst any caner entity, bladder cancer is the most expensive cancer
 regarding follow-up and life-time treatment costs due to the high probability of recurrence.
 Up to 85% of patients initially present with non muscle-invasive bladder cancer (NMIBC).
 Progression to muscle-invasive bladder cancer (MIBC) is up to 10-20%. NMIBC is characterized
 by a high risk of recurrence after transurethral resection of bladder tumor (TURBT): the 1-yr
 recurrence rate is 15-61% and the 5-yr recurrence rate is 31-78%. These numbers represent the
 heterogeneity of NMIBC.

 Against any existing oncological principle, during TURBT bladder tumors are resected in a
 piecemeal manner. This results in tumor fragmentation and floating cancer cells inside the
 bladder during surgery. These cells may have the ability to re-attach on and re-implant into
 the bladder wall and may be responsible for early disease recurrence which is commonly seen
 after initial surgery. It has been shown that tumor cells may access the circulatory system
 through cut vessels. Circulating tumor cells (CTCs) can be detected in up to 20% in T1 high
 grade disease and are commonly seen in metastasized disease. They have shown to be an
 independent predictor of disease progression and relapse in several studies and reflect
 biological aggressiveness.

 In the current study the investigators want to quantify CTCs for recurrent intermediate risk
 transitional cell carcinoma in purging fluid and blood for two different surgical methods:
 TURBT and Plasma-kinetic vaporisation of bladder tumors (PKVBT). Also correlations for
 recurrence will be investigated for the two different surgical methods.

 In 2 urological centers (LKH Hall, LKH Salzburg) participants with diagnosed intermediate
 risk recurrent transitional cell carcinoma of the bladder will be randomly enrolled for
 either TURBT or PKVBT. Before surgery CTCs will be analyzed in peripheral blood and purging
 fluid. (preoperative CTCs blood and purging fluid, morphological aspect of CTCs in purging
 fluid) After resection for TURBT and vaporization for PKVBT, a tumor ground biopsy will be
 taken for both groups. After coagluation, CTCs will again be drawn in peripheral blood
 (intraoperative CTCs blood). After completion of surgery an indwelling catheter is inserted
 and purging fluid is again analyzed (postoperative CTCs purging fluid, morphological aspect
 of CTCs in purging fluid). Blood is again taken on day 2 after surgery during the morning
 routine to assess CTCs after surgery (postoperative CTCs blood). Patients will be dismissed
 on earliest day 2 after surgery after indwelling catheter removal.

 Recurrence will be assessed during follow-up by cystoscopic controls (From 3 to 36 months
 after surgery). If recurrence is detected the study is terminated. If no recurrence is
 detected up to 36 months after surgery, the study is likewise terminated.
Inclusion Criteria:

 -  female and male patients

 -  recurrent bladder tumor

 -  preoperative cystoscopy

 -  CT or MRI scan of abdomen not older than 30 days prior to surgery without suspicion of
 advanced disease (MIBC, metastasis)

 -  max. non-invasive papillary tumor (pTa) staging in prior histology

 -  max. low grade grading in prior histology

 -  max. 5 lesions in actual cystoscopy (all < 3cm)

 -  exophytic tumors

 -  transitional cell cancer of urinary bladder

 -  patient able to give consent

 -  signed consent form

 Exclusion Criteria:

 -  initial tumor

 -  flat lesion

 -  > 3cm

 -  carcinoma in situ (CIS) in prior histology or suspicious CIS-finding in actual
 cystoscopy

 -  high grade grading in prior histology

 -  ≥ pT1 (tumor infiltration into subepithelial connective tissue) staging in prior
 histology

 -  > 5 lesions

 -  different entity from transitional cell carcinoma of urinary bladder

 -  prior radiation

 -  emergency surgery

 -  prior indwelling catheter (extraction < 1 week prior to surgery)

 -  pregnancy

 -  orthotopic neobladder