Quality of life after robotic-assisted and laparoscopic radical prostatectomy: Results of a multicenter randomized controlled trial (LAP-01).

BACKGROUND: To explore cross-sectional and longitudinal differences in general health-related and prostate cancer-specific quality of life (QoL) after robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy and to analyze predictive variables for QoL outcomes. METHODS: In this multicenter, randomized controlled trial, prostate cancer patients were randomly assigned 3:1 to undergo either RARP or LRP. Patient-reported outcomes were prospectively collected before and 1, 3, 6, 12 months after radical prostatectomy and included QoL as a secondary outcome. Validated questionnaires were used to assess general health-related (EORTC QLQ-C30) and prostate cancer-specific (QLQ-PR25) QoL. Cross-sectional and longitudinal contrasts were analyzed through linear mixed models. Predictive variables for QoL outcomes were identified by general linear modeling. RESULTS: Of 782 randomized patients, QoL was evaluable in 681 patients. In terms of general QoL, the cross-sectional analysis showed only small differences between study arms, whereas longitudinal comparison indicated an advantage of RARP on recovery: RARP patients reported an earlier return to baseline in global health status (3 vs. 6 months) and social functioning (6 vs. 12 months). In role functioning, only the RARP arm regained baseline scores. Regarding prostate-specific QoL, LRP patients experienced more urinary symptoms and reported 3.2 points (95% confidence interval 0.4-6, p = 0.024) higher mean scores at 1-month follow-up and in mean 2.9 points (0.1-5, p = 0.042) higher urinary symptoms scores at 3-month follow-up than RARP patients. There were no other significant differences between treatment groups. Urinary symptoms, sexual activity, and sexual function remained significantly worse compared with baseline at all time points in both arms. CONCLUSIONS: Compared with LRP, the robotic approach led to an earlier return to baseline in several domains of general health-related QoL and better short-term recovery of urinary symptoms. Predictive variables such as the scale-specific baseline status and bilateral nerve-sparing were confirmed.

Robotic-assisted Versus Laparoscopic Radical Prostatectomy: 12-month Outcomes of the Multicentre Randomised Controlled LAP-01 Trial.

BACKGROUND: Recently, our LAP-01 trial demonstrated superiority of robotic-assisted laparoscopic radical prostatectomy (RARP) over conventional laparoscopic radical prostatectomy (LRP) with respect to continence at 3 mo. OBJECTIVE: To compare the continence, potency, and oncological outcomes between RARP and LRP in the 12-mo follow-up. DESIGN, SETTING, AND PARTICIPANTS: In this multicentre, randomised, patient-blinded controlled trial, patients referred for radical prostatectomy to four hospitals in Germany were randomly assigned (3:1) to undergo either RARP or LRP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Continence was assessed as a patient-reported outcome through validated questionnaires. Secondary endpoints included potency and oncological outcomes. Data were statistically analysed by bivariate tests and multivariable models. RESULTS AND LIMITATIONS: At 12 mo, follow-up data were available for 701 of 782 patients. Continence at 6 and 12 mo after surgery was better in RARP patients, however no longer statistically significant (p = 0.068 and 0.38, respectively). Patients who were potent at baseline and underwent nerve-sparing surgery reported significantly higher potency after RARP, as defined by the capability to maintain an erection sufficient for intercourse at 3 (p = 0.005), 6 (p = 0.018), and 12 mo (p = 0.013). There were no statistically significant differences in oncological outcomes at 12 mo. It is a limitation that the influence of different anastomotic techniques was not investigated in this study. CONCLUSIONS: Both LRP and RARP offer a high standard of therapy for prostate cancer patients. However, robotic assistance offers better functional outcomes in specific areas such as potency and early continence in patients who are eligible for nerve-sparing RP. PATIENT SUMMARY: We compared outcomes 12 mo after radical prostatectomy between robotic-assisted and conventional laparoscopy. Both methods were equivalent with respect to oncological outcomes. Better recovery of continence in patients with robotic-assisted surgery, which was observed at 3 mo, blurred up to 12 mo. A benefit of robotic-assisted surgery was also observed in potency.

Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose?

OBJECTIVE: Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives. MATERIALS AND METHODS: LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads. RESULTS: 310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038). CONCLUSION: From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective. TRIAL REGISTRATION: The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01).

BACKGROUND: The LAP-01 trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy. OBJECTIVE: To compare the functional and oncological outcomes between RARP and LRP at 3 mo of follow-up. DESIGN, SETTING, AND PARTICIPANTS: In this multicentre, randomised, patient-blinded controlled trial, patients referred for radical prostatectomy to four hospitals in Germany were randomly assigned (3:1) to undergo either RARP or LRP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was time to continence recovery at 3 mo based on the patient's pad diary. Secondary outcomes included continence and potency as well as quality of life in addition to oncological outcomes for up to 3 yr of follow-up. Time to continence was analysed by log-rank test and depicted by the Kaplan-Meier method. Continuous measurements were analysed by means of linear mixed models. RESULTS AND LIMITATIONS: A total of 782 patients were randomised. The primary endpoint was evaluable in 718 patients (547 RARPs; full analysis set). At 3 mo, the difference in continence rates was 8.7% in favour of RARP (54% vs 46%, p = 0.027). RARP remained superior to LRP even after adjustment for the randomisation stratum nerve sparing and age >65 yr (hazard ratio = 1.40 [1.09-1.81], p = 0.008). A significant benefit in early potency recovery was also identified, while similar oncological and morbidity outcomes were documented. It is a limitation that the influence of different anastomotic techniques was not investigated in this study. CONCLUSIONS: RARP resulted in significantly better continence recovery at 3 mo. PATIENT SUMMARY: In this randomised trial, we looked at the outcomes following radical prostate surgery in a large German population. We conclude that patients undergoing robotic prostatectomy had better continence than those undergoing laparoscopic surgery when assessed at 3 mo following surgery. Age and the nerve-sparing technique further affected continence restoration.

Prospective comparison of whole-body MRI and 68Ga-PSMA PET/CT for the detection of biochemical recurrence of prostate cancer after radical prostatectomy.

PURPOSE: To assess whole-body magnetic resonance imaging (wb-MRI) for detection of biochemical recurrence in comparison to 68Ga-prostate-specific membrane antigen positron emission tomography/computed tomography (68Ga-PSMA PET/CT) in prostate cancer (Pca) patients after radical prostatectomy. METHODS: This was a prospective trial including 28 consecutive patients (mean age 65.3 ± 9.0 years) with newly documented biochemical recurrence of Pca (mean prostate-specific antigen, PSA, 2.09 ± 1.95 ng/ml) following radical prostatectomy. All patients underwent both wb-MRI including a dedicated pelvic imaging protocol and PET/CT with 166 ± 35 MBq 68Ga-PSMA within a time window of 11 ± 10 days. PET/CT and MRI datasets were separately evaluated regarding Pca lesion count, type, localization and diagnostic confidence (three-point Likert scale, 1-3) by two nuclear medicine specialists and two radiologists, respectively. The reference standard was based on histopathological results, PSA levels following targeted salvage irradiation and follow-up imaging. Lesion-based and patient-based detection rates were compared using the chi-squared test. Differences in diagnostic confidence were assessed using the Welch test. RESULTS: A total of 56 Pca lesions were detected in 20 of the 28 patients. 68Ga-PSMA PET/CT detected 56 of 56 lesions (100%) in 20 patients (71.4%), while wb-MRI detected 13 lesions (23.2%) in 11 patients (39.3%). The higher detection rate with 68Ga-PSMA PET/CT was statistically significant on both a per-lesion basis (p < 0.001) and a per-patient basis (p = 0.0167). In 8 patients (28.6%) no relapse was detectable by either modality. All lesions detected by wb-MRI were also detected by 68Ga-PSMA PET/CT. Additionally, 68Ga-PSMA PET/CT provided superior diagnostic confidence in identifying Pca lesions (2.7 ± 0.7 vs. 2.3 ± 0.6, p = 0.044). CONCLUSION: 68Ga-PSMA PET/CT significantly out-performed wb-MRI in the detection of biochemical recurrence in Pca patients after radical prostatectomy.

Oncological outcome of patients treated with spot-specific salvage lymphnode dissection (sLND) for positron-emission tomography (PET)-positive prostate cancer (PCa) relapse.

OBJECTIVES: To report pre-, postoperative and oncological outcomes in patients treated with spot-specific sLND for patients with exclusive nodal recurrence after PCa primary treatment. MATERIALS AND METHODS: With regard to salvage treatment failure (sTF), 46 consecutive patients, undergoing 52 sLND for nodal recurrence detected by PET/CT scan were stratified in 3 groups (group A: post-sLND PSA nadir < 0.01 ng/ml and in follow-up reaching a value > 0.2 ng/ml, group B: post-sLND PSA nadir > 0.01 ng/ml and in follow-up reaching a value equal to pre-sLND PSA; group C: additional salvage treatment administration). Surgical outcome of patients was analyzed by descriptive statistics (Student's t test for continuous variables, Chi-square and Fisher's test for categorial ones). Time to sTF of each group was analyzed and compared by Kaplan-Meier method and correlations regarding sTF and pre-sLND PSA, time from PCa primary treatment to PET/CT scan, time from PCa primary treatment to sLND and number of positive PET/CT scan spots were assessed. RESULTS: Median PSA at PET/CT scan was 2.9 ng/ml (IQR 1.2-6.1). Open and laparoscopic sLND were performed in 40/52 (77%) and 12/52 (23%), respectively. Median number of removed lymph nodes was 6 (IQR 4-13). Histological report was positive for PCa in 39/52 sLND (75%). Median blood loss was 50 ml (IQR 0-50, range 0-600). Median length of hospital stay was 5 days (IQR 4-6). 4 and 7 patients had low-grade (I/II) and high-grade (≥ III) Clavien-Dindo complications, respectively. Readmission rates at 30 and 90 days were 5/52 (9.6%) and 1/52 (2%), respectively. sTF was observed in 2/7 (group A), 12/12 (group B) and 22/22 patients (group C). Median time to sTF in group B and C was 3.5 (IQR 1.7-13.2) and 4 months (IQR 2.0-10), respectively. CONCLUSION: Even spot-specific PET/CT sLND harbors a measurable (CD > III) morbidity in 1 out of 7 patients. Only patients with positive histological report and a PSA nadir < 0.01 ng/ml after sLND seem to experience a long-term benefit. Patients with a PSA nadir > 0.01 ng/ml have a delay of systemic treatment of up to 4 months. sLND remains an experimental approach and long-term oncological benefit needs an improved selection of patients.

Comparison of 2-Year Oncological Outcome and Early Recurrence Patterns in Patients with Urothelial Bladder Carcinoma Treated with Open or Robot-Assisted Radical Cystectomy with an Extracorporeal Urinary Diversion.

BACKGROUND: Data on oncological follow-up after robotic-assisted radical cystectomy (RARC) have been reported only scarcely and individual studies have reported an increase in early recurrences and atypical recurrences. PATIENTS AND METHODS: Clinical data of 89 patients with RARC were compared to 59 patients with open radical cystectomy (ORC) at a single institution. Two-year cancer-specific (2y-CSS) and 2-year overall survival (2y-OS) related to histopathological tumor stage of RARC patients calculated by Kaplan-Meier method were compared to ORC patients using log-rank test. Early clinical recurrence rate (eCR, progression ≤6 months post-cystectomy) and metastatic pattern of both groups were compared by chi-square test. RESULTS: Median follow-up 32 months (RARC) and 47.5 months (ORC), both groups were balanced in baseline characteristics. For RARC pts, -2y-OS and CSS-free survival rates were 80 and 90%, for ORC pts 65 and 71% (all p > 0.05). Margin status was not significantly different. eCR was observed in 10 out of 89 (11%) RARC pts and in 7 out of 59 (12%) ORC pts (p = 0.9). No difference in atypical metastases was seen between groups. CONCLUSION: Two-year oncological outcomes of RARC patients are comparable to ORC patients without differences regarding ePR or metastatic pattern.

Multiparametric Magnetic Resonance Imaging/Ultrasound Fusion Prostate Biopsy-Are 2 Biopsy Cores per Magnetic Resonance Imaging Lesion Required?

PURPOSE: For multiparametric magnetic resonance imaging/ultrasound fusion prostate biopsy the number of biopsy cores obtained is arbitrarily established by urologists. Moreover, a general consensus is lacking on the number of biopsy cores to be obtained from a single magnetic resonance imaging lesion. Therefore, we evaluated the feasibility of obtaining only 1 biopsy core per magnetic resonance imaging lesion. MATERIALS AND METHODS: We retrospectively evaluated a total of 2,128 biopsy cores of 1,064 prostatic lesions (2 cores per lesion) in 418 patients in regard to prostate cancer detection (histology) and the Gleason score of the first biopsy core compared to the second biopsy core. Two analyses were performed, including patient level analysis based on prostate cancer detection per patient and lesion level analysis based exclusively on the histology of each lesion regardless of the overall histological outcome of the case. RESULTS: The overall prostate cancer detection rate was 45.7% (191 of 418 patients). The first biopsy core detected 170 of all 191 prostate cancers (89%). In 17 of these 170 prostate cancers (10%) the second biopsy core revealed Gleason score upgrading. Nine of the 21 prostate cancers (43%) missed by the first biopsy core had a Gleason score of 6. Altogether 537 of the 2,128 biopsy cores were positive, including 283 first (26.6%) and 254 second (24%) biopsy cores (p ≤0.001). The concordance between the first and second biopsy cores was 89% (κ = 0.71). There was a discrepancy with Gleason score upgrading in 28 of 212 lesions (13.2%) with positive first and second biopsy cores. CONCLUSIONS: Our study shows that obtaining more than 1 biopsy core per magnetic resonance imaging lesion only slightly improves the prostate cancer detection rate and Gleason grading.

Current Utilization and Acceptance of Multiparametric MRI in the Diagnosis of Prostate Cancer. A Regional Survey.

PURPOSE: To assess the current regional acceptance, valuation, and clinical role of multiparametric MRI (mp-MRI) in prostate cancer diagnostics by patients and physicians. MATERIALS AND METHODS: Of 482 distributed standardized questionnaires, 328 patient and 31 physician questionnaires (urological and general practitioners in and around Düsseldorf) were analyzed over a period of 11 months. Questions were asked concerning general knowledge about prostate cancer, current diagnostic procedures, and knowledge about mp-MRI and MRI-guided biopsy. RESULTS: 70 % of the patients regarded accurate and exact diagnostics of prostate carcinomas as very important and 68 % considered MP-MRI a useful technique. 28 % of the patients with elevated PSA levels and negative transrectal ultrasound-guided biopsy (TRUS-GB) received MP-MRI as a secondary diagnostic. More than half of the patients estimated their overall knowledge about prostate cancer mediocre or worse and wished for more information about MR diagnostics. The majority of physicians (55 %) ordered MP-MRI studies of the prostate and 68 % saw their basic role in secondary diagnostics. CONCLUSION: In this regional assessment mp-MRI of the prostate was considered useful by patients and practitioners. Currently, there still is a considerable discrepancy between recommended and the actual number of conducted MP-MRI studies, particularly in patients after previous negative TRUS-GB, although practitioners already see the benefit in this patient collective. Even though the use of prostate MRI is frequently more established than suggested in the current German S3-guideline, its full potential has not yet been exploited. More comprehensive information about the applications and diagnostic benefits of prostate MRI is needed and desired among patients and physicians. KEY POINTS: · The use of prostate MRI is frequently more established than suggested in the current German S3-guideline (12/2016). · The full potential of mp-MRI of the prostate has not been exploited. · More information about the clinical benefit and potential of prostate MRI is necessary and desired by patients and clinicians. CITATION FORMAT: · Ullrich T, Schimmöller L, Oymanns M et al. Current Utilization and Acceptance of Multiparametric MRI in the Diagnosis of Prostate Cancer. A Regional Survey. Fortschr Röntgenstr 2018; 190: 419 - 426.

Risk Stratification of Equivocal Lesions on Multiparametric Magnetic Resonance Imaging of the Prostate.

PURPOSE: We systematically analyzed the records of patients with PI-RADS™ (Prostate Imaging Reporting and Data System) 3 lesions, which are called equivocal according to PI-RADS version 2, using prostate multiparametric magnetic resonance imaging and magnetic resonance imaging targeted biopsies. Systematic transrectal ultrasound guided biopsies served as the reference standard. MATERIALS AND METHODS: A total of 120 consecutive patients were retrospectively included in the study. In these patients the overall PI-RADS score was 3 after 3 Tesla T2-weighted imaging, diffusion weighted imaging and dynamic contrast enhanced multiparametric magnetic resonance imaging as well as subsequent targeted magnetic resonance imaging/ultrasound fusion guided biopsies plus systematic 12-core transrectal ultrasound guided biopsies. The study end points were the prostate cancer detection rate, the Gleason score distribution, the prostate cancer location and risk stratification by subgroup analyses. RESULTS: Prostate cancer was detected in 13 of 118 patients for a detection rate of 11%, including 5 patients (4.2%) with a Gleason score of 3 + 4 = 7 or greater. Three of the 212 lesions (1.4%) in the transition zone and 6 of the 64 (9.4%) in the peripheral zone were positive for prostate cancer. Multiparametric magnetic resonance imaging revealed patterns of peripheral prostatitis combined with diffuse stromal hyperplasia in 54% of the patients with prostate cancer. Prostate volume was significantly lower in patients with prostate cancer (p = 0.015) but differences in prostate specific antigen levels were not statistically significant (p = 0.87). Prostate specific antigen density was higher in patients with prostate cancer (0.19 vs 0.12 ng/ml/ml). CONCLUSIONS: Low grade prostate cancer (Gleason score 3 + 3 = 6) can develop in patients with an overall PI-RADS score of 3. Prostate cancer with a Gleason score of 3 + 4 = 7 or greater can be detected by multiparametric magnetic resonance imaging with a high degree of certainty. Gleason score 4 + 3 = 7 or greater prostate cancer is unlikely in PI-RADS 3 lesions. Therefore, these patients should primarily undergo followup multiparametric magnetic resonance imaging. In patients with a combination of multiparametric magnetic resonance imaging aspects of extensive prostatitis and diffuse stromal hyperplasia low prostate volume and/or high prostate specific antigen density biopsy might be considered.

Evaluation of Practical Interpretation Hurdles in 68Ga-PSMA PET/CT in 55 Patients: Physiological Tracer Distribution and Incidental Tracer Uptake.

PURPOSE: To investigate the physiologic Ga-PSMA distribution and evaluate focal or diffuse radiotracer uptake in nonprostate cancer malignancies and in incidental findings. METHODS: Ga-PSMA PET/CT scans in 55 men performed for prostate cancer (49) or renal cell carcinoma (6) staging were analyzed retrospectively. Two radiologists evaluated the datasets in 2 reading sessions. First, physiological Ga-PSMA uptake was evaluated. Second, scans were analyzed for incidental uptake. SUVmax and SUVmean were recorded. Other imaging modalities, histopathology, or clinical follow-up served as standard of reference. RESULTS: Homogenous Ga-PSMA uptake of the lacrimal glands (SUVmax, 15.7 ± 7.2), parotid glands (SUVmax, 24.4 ± 8.1), submandibular glands (SUVmax, 26.7 ± 7.1), vocal cords (SUVmax, 8.4 ± 3), Waldeyer ring (SUVmax, 10.4 ± 4.3), liver (SUVmax, 8.2 ± 2.5), spleen (SUVmax, 10.9 ± 3.9), kidneys (SUVmax, 66.4 ± 25.4), and pars descendens duodeni (SUVmax, 17.6 ± 8.9) was observed in all patients. In 65% and 36%, respectively, homogenous Ga-PSMA uptake of the colon descendens (SUVmax, 10.6 ± 9.2) and the rectum (SUVmax, 3.7 ± 1.1) was found. Approximately 22% exhibited a Ga-PSMA uptake of the thyroid (SUVmax, 4.5 ± 1.2), and 21% exhibited a Ga-PSMA uptake of the knee's synovia (SUVmax, 2.9 ± 0.2). Furthermore, Ga-PSMA uptake was found in 1 patient because of fibrous dysplasia of the right os ilium (SUVmax, 7.7). CONCLUSIONS: Physiologic distribution of Ga-PSMA comprises uptake in lacrimal and salivary glands, vocal cords, Waldeyer ring, liver, spleen, and kidneys as well as various parts of the intestine. Moreover, nonspecific tracer uptake is regularly found in the thyroid and the synovia of the knee. Incidental Ga-PSMA uptake can occasionally reveal nonprostate cancer-associated remodeling processes, such as fibrous dysplasia.

MRI-Guided In-Bore Biopsy: Differences Between Prostate Cancer Detection and Localization in Primary and Secondary Biopsy Settings.

OBJECTIVE: The objective of our study was to evaluate transrectal MRI-guided in-bore biopsy in patients who either were biopsy-naive (primary biopsy) or had undergone at least one previous negative transrectal ultrasound-guided biopsy (secondary biopsy) with regard to cancer detection rate, tumor localization, and lesion size. MATERIALS AND METHODS: In total, 1602 biopsy cores from 297 consecutive patients (mean ± SD, 66.1 ± 7.8 years; median prostate-specific antigen value, 8.2 ng/mL) in primary (n = 160) and secondary (n = 137) prostate biopsy settings were evaluated in this retrospective study. All patients previously underwent prostate MRI (T2-weighted imaging, DWI, dynamic contrast-enhanced imaging) at 3 T. All described lesions were biopsied with MRI-guided in-bore biopsy and were examined histologically. RESULTS: In 148 patients, overall 511 cores were positive for prostate cancer. Clinically significant prostate cancer (any Gleason pattern ≥ 4) was found in 82.4% of patients. The prostate cancer detection rate for patients who underwent primary biopsies was 55.6% and was 43.1% for patients who underwent secondary biopsies. In patients with primary versus secondary biopsies, prostate cancer was located peripherally in 62.9% versus 49.5% (p = 0.04), in the transition zone in 27.4% versus 27.5% (p = 1.0), and in the anterior stroma in 10.3% versus 22.9% (p < 0.01), respectively. The prostate cancer detection rates for patients with smaller prostate volumes (< 30 vs 30-50 vs > 50 mL; p < 0.01) or for patients with larger lesions (> 0.5 vs 0.25-0.5 vs < 0.25 cm(3); p < 0.01) were significantly higher. CONCLUSION: MRI-guided in-bore biopsy led to high detection rates in primary and secondary prostate biopsies. Prostate cancer detection rates were significantly higher for patients with larger lesions and smaller prostate glands. In patients who underwent secondary biopsies, prostate cancer was located in the anterior stroma at a significantly more frequent rate.

Comparison of patient comfort between MR-guided in-bore and MRI/ultrasound fusion-guided prostate biopsies within a prospective randomized trial.

PURPOSE: The objective of this study was to compare patient comfort between MR-guided in-bore prostate biopsy (IB-GB) and MRI/ultrasound fusion-guided prostate biopsy (FUS-GB) with additional systematic 12-core transrectal ultrasound (TRUS)-guided biopsy within a prospective randomized trial. METHODS: Two hundred and ten consecutive patients were randomly assigned in a 1:1 ratio to receive either IB-GB and prior intrarectal instillation of a 2% lidocaine gel (n = 106) or FUS-GB plus additional systematic 12-core TRUS-guided biopsy and prior application of a periprostatic nerve block (PPNB) with 2% mepivacaine (n = 104). The maximal procedural pain (MPP) on a 0-10 visual analog scale and the operating room time were recorded for each biopsy session. RESULTS: Baseline characteristics and mean number of targeted biopsy cores (5.6 ± 0.8 vs 5.4 ± 1.2 for IB-GB and FUS-GB, respectively; p = 0.278) were similar in both study arms. In relation to the IB-GB arm, the total number of biopsy cores in the FUS-GB arm, including the systematic 12-core TRUS-guided biopsy, was significantly higher (17.4 ± 1.2; p < 0.001). Patients with IB-GB had significantly higher MPP scores (2.95 ± 2.15) compared with subjects with FUS-GB (1.95 ± 1.56; p < 0.001). FUS-GB required significantly less time (28.22 ± 11.61 min) in comparison with IB-GB (42.09 ± 11.37 min; p < 0.001). CONCLUSIONS: The PPNB can easily be administered just prior to performing FUS-GB. Thus, patients have significantly lower pain levels in comparison with IB-GB, which is usually done with intrarectal anesthetic gels. Although the addition of a systematic 12-core TRUS-guided biopsy significantly increases the number of biopsy cores, FUS-GB still requires significantly less time in comparison with IB-GB.

Prospective randomized trial comparing magnetic resonance imaging (MRI)-guided in-bore biopsy to MRI-ultrasound fusion and transrectal ultrasound-guided prostate biopsy in patients with prior negative biopsies.

BACKGROUND: A significant proportion of prostate cancers (PCas) are missed by conventional transrectal ultrasound-guided biopsy (TRUS-GB). It remains unclear whether the combined approach using targeted magnetic resonance imaging (MRI)-ultrasound fusion-guided biopsy (FUS-GB) and systematic TRUS-GB is superior to targeted MRI-guided in-bore biopsy (IB-GB) for PCa detection. OBJECTIVE: To compare PCa detection between IB-GB alone and FUS-GB + TRUS-GB in patients with at least one negative TRUS-GB and prostate-specific antigen ≥4 ng/ml. DESIGN, SETTING, AND PARTICIPANTS: Patients were prospectively randomized after multiparametric prostate MRI to IB-GB (arm A) or FUS-GB + TRUS-GB (arm B) from November 2011 to July 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The study was powered at 80% to demonstrate an overall PCa detection rate of ≥60% in arm B compared to 40% in arm A. Secondary endpoints were the distribution of highest Gleason scores, the rate of detection of significant PCa (Gleason ≥7), the number of biopsy cores to detect one (significant) PCa, the positivity rate for biopsy cores, and tumor involvement per biopsy core. RESULTS AND LIMITATIONS: The study was halted after interim analysis because the primary endpoint was not met. The trial enrolled 267 patients, of whom 210 were analyzed (106 randomized to arm A and 104 to arm B). PCa detection was 37% in arm A and 39% in arm B (95% confidence interval for difference, -16% to 11%; p=0.7). Detection rates for significant PCa (29% vs 32%; p=0.7) and the highest percentage tumor involvement per biopsy core (48% vs 42%; p=0.4) were similar between the arms. The mean number of cores was 5.6 versus 17 (p<0.001). A limitation is the limited number of patients because of early cessation of accrual. CONCLUSIONS: This trial failed to identify an important improvement in detection rate for the combined biopsy approach over MRI-targeted biopsy alone. A prospective comparison between MRI-targeted biopsy alone and systematic TRUS-GB is justified. PATIENT SUMMARY: Our randomized study showed similar prostate cancer detection rates between targeted prostate biopsy guided by magnetic resonance imaging and the combination of targeted biopsy and systematic transrectal ultrasound-guided prostate biopsy. An important improvement in detection rates using the combined biopsy approach can be excluded.

The use of targeted MR-guided prostate biopsy reduces the risk of Gleason upgrading on radical prostatectomy.

PURPOSE: Gleason grading is the strongest predictor of prostate cancer outcome and commonly used to decide for or against the different treatment options. However, Gleason upgrading between systematic transrectal ultrasound-guided prostate biopsy (TRUS-GB) and radical prostatectomy (RPE) has frequently been observed. With respect to the high accuracy of multiparametric MRI (mpMRI) for high-grade cancers and the higher percentage of cancer involvement per biopsy core in targeted MR-guided prostate biopsy (MR-GB), we hypothesized that MR-GB reduces the risk of Gleason upgrading on RPE as compared to the gold standard. The purpose of this study was to compare the rate of Gleason upgrading on RPE for MR-GB, TRUS-GB, and the combination of both biopsy modalities. METHODS: Overall, 52 consecutive patients with RPE had received an mpMRI of the prostate and subsequently underwent targeted MR-GB prior to surgery. All patients underwent an additional TRUS-GB during the same biopsy session. Gleason grading was measured by two different methods: the conventional Gleason score (cGS = primary + secondary pattern) and the highest Gleason pattern (hGP). RESULTS: In relation to TRUS-GB, MR-GB alone showed lower rates of upgrading when comparing the cGS (40.4 vs. 50.0 %) and the hGP (21.2 vs. 32.7 %). The combination of MR-GB and TRUS-GB showed the lowest rates of upgrading (cGS: 28.8 %; hGP: 11.5 %), and compared to TRUS-GB, significantly reduced the risk of upgrading for both measurements of Gleason grading (cGS: OR 0.41, 95 % CL 0.18-0.91, p = 0.0289; hGP: OR 0.27, 95 % CL 0.10-0.75, p = 0.0123). CONCLUSION: MpMRI and targeted MR-GB are useful tools to better characterize and stage the extent of disease, and therefore enable the urologist to better risk-stratify and counsel the patient. The combined use of targeted MR-GB and TRUS-GB presents the least risk of Gleason underestimation.

Perioperative complications and oncological safety of robot-assisted (RARC) vs. open radical cystectomy (ORC).

OBJECTIVES: To assess the surgical and oncological outcome of robot-assisted radical cystectomy (RARC) compared with open radical cystectomy (ORC). PATIENTS AND METHODS: Clinical data of 64 patients undergoing RARC between August 2010 and August 2013 were prospectively documented and retrospectively compared with 79 patients undergoing ORC between August 2008 and August 2013 at a single academic institution. Perioperative results, surgical margins status, and nodal yield after RARC and ORC were compared using Mann-Whitney U test (continuous variables) and chi-square test (categorical variables). Additional age-stratified analysis was performed in elderly patients (≥75 y). To avoid inference errors by multiple testing, P-values were adjusted using Bonferroni׳s correction. RESULTS: Baseline characteristics of both cohorts were balanced. RARC patients had significantly less blood loss (RARC: 300 [interquartile range {IQR}: 200-500]ml; perioperative transfusion rate: 0 [IQR: 0-2] red packed blood cells [RPBCs]; ORC: 800 [IQR: 500-1200]ml, P<0.01; transfusion rate: 3 [IQR: 2-4] RPBCs, P<0.01), and hospital stay of RARC patients was reduced by 20% (RARC: 13 [IQR: 9-17]d, ORC: 16 [IQR: 13-21]d, P< 0.01). A total of 55 patients who underwent RARC and 59 patients who underwent ORC were eligible for analysis of oncological surrogates "surgical margin status" and "lymph-node yield" as well as for survival data. No differences between patients undergoing RARC or ORC were observed. In elderly patients (≥75 y; RARC: 17 patients, ORC: 28 patients), decreased intraoperative blood loss (RARC: 300 [IQR: 100-475]ml; ORC: 800 [IQR: 400-1300]ml, P<0.01) and lower transfusion rate (RARC: 0 [IQR: 0-1] RPBCs; ORC: 4 [IQR: 2-5] RPBCs, P<0.01) were observed in the robotic group. Major limitations of this study are the retrospective study design and a potential selection bias. CONCLUSIONS: RARC provides significant advantages compared with ORC regarding blood loss and postoperative recovery, whereas surgical and oncological outcomes are not different.

MR-sequences for prostate cancer diagnostics: validation based on the PI-RADS scoring system and targeted MR-guided in-bore biopsy.

PURPOSE: This study evaluated the accuracy of MR sequences [T2-, diffusion-weighted, and dynamic contrast-enhanced (T2WI, DWI, and DCE) imaging] at 3T, based on the European Society of Urogenital Radiology (ESUR) scoring system [Prostate Imaging Reporting and Data System (PI-RADS)] using MR-guided in-bore prostate biopsies as reference standard. METHODS: In 235 consecutive patients [aged 65.7 ± 7.9 years; median prostate-specific antigen (PSA) 8 ng/ml] with multiparametric prostate MRI (mp-MRI), 566 lesions were scored according to PI-RADS. Histology of all lesions was obtained by targeted MR-guided in-bore biopsy. RESULTS: In 200 lesions, biopsy revealed prostate cancer (PCa). The area under the curve (AUC) for cancer detection was 0.70 (T2WI), 0.80 (DWI), and 0.74 (DCE). A combination of T2WI + DWI, T2WI + DCE, and DWI + DCE achieved an AUC of 0.81, 0.78, and 0.79. A summed PI-RADS score of T2WI + DWI + DCE achieved an AUC of 0.81. For higher grade PCa (primary Gleason pattern ≥ 4), the AUC was 0.85 for T2WI + DWI, 0.84 for T2WI + DCE, 0.86 for DWI + DCE, and 0.87 for T2WI + DWI + DCE. The AUC for T2WI + DWI + DCE for transitional-zone PCa was 0.73, and for the peripheral zone 0.88. Regarding higher-grade PCa, AUC for transitional-zone PCa was 0.88, and for peripheral zone 0.96. CONCLUSION: The combination of T2WI + DWI + DCE achieved the highest test accuracy, especially in patients with higher-grade PCa. The use of ≤2 MR sequences led to lower AUC in higher-grade and peripheral-zone cancers. KEY POINTS: • T2WI + DWI + DCE achieved the highest accuracy in patients with higher grade PCa • T2WI + DWI + DCE was more accurate for peripheral- than for transitional-zone PCa • DCE increased PCa detection accuracy in the peripheral zone • DWI was the leading sequence in the transitional zone.

Prospective evaluation of magnetic resonance imaging guided in-bore prostate biopsy versus systematic transrectal ultrasound guided prostate biopsy in biopsy naïve men with elevated prostate specific antigen.

PURPOSE: Magnetic resonance imaging guided biopsy is increasingly performed to diagnose prostate cancer. However, there is a lack of well controlled, prospective trials to support this treatment method. We prospectively compared magnetic resonance imaging guided in-bore biopsy with standard systematic transrectal ultrasound guided biopsy in biopsy naïve men with increased prostate specific antigen. MATERIALS AND METHODS: We performed a prospective study in 132 biopsy naïve men with increased prostate specific antigen (greater than 4 ng/ml). After 3 Tesla functional multiparametric magnetic resonance imaging patients were referred for magnetic resonance imaging guided in-bore biopsy of prostate lesions (maximum 3) followed by standard systematic transrectal ultrasound guided biopsy (12 cores). We analyzed the detection rates of prostate cancer and significant prostate cancer (greater than 5 mm total cancer length or any Gleason pattern greater than 3). RESULTS: A total of 128 patients with a mean ± SD age of 66.1 ± 8.1 years met all study requirements. Median prostate specific antigen was 6.7 ng/ml (IQR 5.1-9.0). Transrectal ultrasound and magnetic resonance imaging guided biopsies provided the same 53.1% detection rate, including 79.4% and 85.3%, respectively, for significant prostate cancer. Magnetic resonance imaging and transrectal ultrasound guided biopsies missed 7.8% and 9.4% of clinically significant prostate cancers, respectively. Magnetic resonance imaging biopsy required significantly fewer cores and revealed a higher percent of cancer involvement per biopsy core (each p <0.01). Combining the 2 methods provided a 60.9% detection rate with an 82.1% rate for significant prostate cancer. CONCLUSIONS: Magnetic resonance imaging guided in-bore and systematic transrectal ultrasound guided biopsies achieved equally high detection rates in biopsy naïve patients with increased prostate specific antigen. Magnetic resonance imaging guided in-bore biopsies required significantly fewer cores and revealed a significantly higher percent of cancer involvement per biopsy core.

Feasibility of diffusional kurtosis tensor imaging in prostate MRI for the assessment of prostate cancer: preliminary results.

PURPOSE: To assess the feasibility of full diffusional kurtosis tensor imaging (DKI) in prostate MRI in clinical routine. Histopathological correlation was achieved by targeted biopsy. MATERIALS AND METHODS: Thirty-one men were prospectively included in the study. Twenty-one were referred to our hospital with increased prostate specific antigen (PSA) values (>4ng/ml) and suspicion of prostate cancer. The other 10 men were volunteers without any history of prostate disease. DKI applying diffusion gradients in 20 different spatial directions with four b-values (0, 300, 600, 1000s/mm(2)) was performed additionally to standard functional prostate MRI. Region of interest (ROI)-based measurements were performed in all histopathologically verified lesions of every patient, as well as in the peripheral zone, and the central gland of each volunteer. RESULTS: DKI showed a substantially better fit to the diffusion-weighted signal than the monoexponential apparent diffusion coefficient (ADC). Altogether, 29 lesions were biopsied in 14 different patients with the following results: Gleason score 3+3=6 (n=1), 3+4=7 (n=7), 4+3=7 (n=6), 4+4=8 (n=1), and 4+5=9 (n=2), and prostatitis (n=12). Values of axial (Kax) and mean kurtosis (Kmean) were significantly different in the tumor (Kax 1.78±0.39, Kmean 1.84±0.43) compared with the normal peripheral zone (Kax 1.09±0.12, Kmean 1.16±0.13; p<0.001) or the central gland (Kax 1.40±0.12, Kmean 1.44±0.17; p=0.01 respectively). There was a minor correlation between axial kurtosis (r=0.19) and the Gleason score. CONCLUSION: Full DKI is feasible to utilize in a routine clinical setting. Although there is some overlap some DKI parameters can significantly distinguish prostate cancer from the central gland or the normal peripheral zone. Nevertheless, the additional value of DKI compared with conventional monoexponential ADC calculation remains questionable and requires further research.