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Purpose To reach standardized terminology in focal therapy (FT) for prostate cancer (PCa). Methods A four-stage modified Delphi consensus project was undertaken among a panel of international experts in the field of FT for PCa. Data on terminology in FT was collected from the panel by three rounds of online questionnaires. During a face-to-face meeting on June 21, 2015, attended by 38 experts, all data from the online rounds were reviewed and recommendations for definitions were formulated. Results Consensus was attained on 23 of 27 topics; Targeted FT was defined as a lesion-based treatment strategy, treating all identified significant cancer foci; FT was generically defined as an anatomy-based (zonal) treatment strategy. Treatment failure due to the ablative energy inadequately destroying treated tissue is defined as ablation failure. In targeting failure the energy is not adequately applied to the tumor spatially and selection failure occurs when a patient was wrongfully selected for FT. No definition of biochemical recurrence can be recommended based on the current data. Important definitions for outcome measures are potency (minimum IIEF-5 score of 21), incontinence (new need for pads or leakage) and deterioration in urinary function (increase in IPSS >5 points). No agreement on the best quality of life tool was established, but UCLA-EPIC and EORTC-QLQ-30 were most commonly supported by the experts. A complete overview of statements is presented in the text. Conclusion Focal therapy is an emerging field of PCa therapeutics. Standardization of definitions helps to create comparable research results and facilitate clear communication in clinical practice.

HintergrundHochintensiver fokussierter Ultraschall (HIFU) wird seit Anfang der 90er Jahre als alternative Behandlungsform beim Prostatakarzinom eingesetzt.Ziel der ArbeitÜbersicht über den aktuellen Stand und kritische Betrachtung der verschiedenen Indikationen des HIFU beim Prostatakarzinom.Material und MethodenReview der aktuellen Literatur zu Indikationen, Nebenwirkungen, onkologischen Ergebnissen und Leitlinienempfehlungen.ErgebnisseDas Prinzip basiert auf hochenergetischen Schallwellen, die durch Fokussierung zu einer Koagulationsnekrose führen. HIFU kann in unterschiedlichen Indikationen eingesetzt werden: beim Whole-gland-HIFU (Behandlung der kompletten Prostata) wird in der Primärtherapie des lokal begrenzten Prostatakarzinoms eine Ablation des kompletten Prostatagewebes angestrebt. Es liegen mehrere Fallserien mit einem maximalen medianen Follow-up von 8,1 Jahren vor. Die Hauptnebenwirkung ist die Ausbildung einer Blasenhalssklerose. Eine weitere Indikation ist der Salvage-HIFU bei Patienten mit Lokalrezidiv nach primärer Strahlentherapie. Aufgrund des erhöhten Risikos einer Inkontinenz sowie rektourethralen Fistelbildung muss die Indikation vorsichtig gestellt werden. Als innovative Feld gilt die fokale Therapie, bei welcher mithilfe des HIFU eine Teilbehandlung des tumortragenden Anteils der Prostata erfolgt. Durch technische Weiterentwicklungen ist eine Therapieplanung mit Fusion eines multiparametrischen Magnetresonanztomogramms (mpMRT) möglich. Aufgrund des experimentellen Charakters soll diese Therapieform in Studien erfolgen.DiskussionAufgrund fehlender prospektiv randomisierter Studien sowie limitierter Langzeitdaten wird der Whole-gland-HIFU in den Leitlinien europäischer Länder unterschiedlich bewertet. Die fokale Therapie gilt als experimentell und soll daher nur in Studien durchgeführt werden.

In multivariate analysis, GS of the regular prostatectomy specimen was the only statistically significant parameter for pT2R1 prostate cancer.

Purpose To predict biochemical recurrence respecting the natural course of pT2 prostate cancer with positive surgical margin (R1) and no adjuvant/neoadjuvant therapy. Methods A multicenter data analysis of 956 patients with pT2R1N0/Nx tumors was performed. Patients underwent radical prostatectomy between 1994 and 2009. No patients received neoadjuvant or adjuvant therapy. All prostate specimens were re-evaluated according to a well-defined protocol. The association of pathological and clinical features, in regard to BCR, was calculated using various statistical tests. Results With a mean follow-up of 48 months, BCR was found in 25.4 %. In univariate analysis, multiple parameters such as tumor volume, PSA, Gleason at positive margin were significantly associated with BCR. However, in multivariate analysis, Gleason score (GS) of the prostatectomy specimen was the only significant parameter for BCR. Median time to recurrence for GS ≤ 6 was not reached; 5-year BCR-free survival was 82 %; and they were 127 months and 72 % for GS 3+4, 56 months and 54 % for GS 4 + 3, and 27 months and 32 % for GS 8–10. The retrospective approach is a limitation of our study. Conclusions Our study provides data on the BCR in pT2R1-PCa without adjuvant/neoadjuvant therapy and thus a rationale for an individual’s risk stratification. The data support patients and physicians in estimating the individual risk and timing of BCR and thus serve to personalize the management in pT2R1-PCa.

Background: To analyze data on patients with localized prostate cancer who were treated with complete high-intensity focused ultrasound (HIFU) prospectively captured within a voluntary HIFU user database (@-Registry). Methods: The @-Registry includes data from consecutive patients treated with Ablatherm (EDAP-TMS) HIFU at nine European Centres during the period 1994 and 2009. For this analysis, the data repository was reviewed for information on patients with localized prostate cancer (T1–T2) treated with complete (whole-gland) HIFU on the basis of an anterior-posterior prostate height of ⩽24 mm and a treated volume >120% of the prostate volume. Patients were regularly followed with PSA measurement and biopsy. Biochemical failure was defined for this study as PSA nadir +2 ng ml −1 (Phoenix definition). Disease-free survival was based on a biopsy, retreatment and biochemical data. Patients were risk group-stratified using the D'Amico classification system. Results: The median follow-up was 2.8 years for the 356 patients included in the analysis. The majority could be classified as either low (44.9%) or intermediate risk (39.6%); 14.6% patients were classified as high risk. The median (mean, s.d.) PSA nadir was 0.11 ng ml −1 (0.78 and 3.6), achieved at a mean (s.d.) of 14.4 (11.6) weeks after HIFU. Follow-up biopsies on 226/356 (63.5%) patients revealed an overall negative biopsy rate of 80.5% (182/226); there was no statistically significant difference in positive biopsy rate by risk group-stratification. Actuarial freedom from biochemical recurrence at 5 and 7 years according to the Phoenix definition was 85% and 79%, respectively. Disease-free progression rates at 5 and 7 years were 64% and 54%, respectively. Conclusions: Whole-gland prostate HIFU as primary monotherapy for localized prostate cancer achieves a recurrence-free survival in short-term analysis as assessed by prostate biopsy and serum PSA endpoints in a majority of patients.

Purpose To overcome the difficulties in the interpretation of postoperative tumor obtaining biopsy cores for patients who treated their prostate cancer with high-intensity focussed ultrasound (HIFU) therapy. Methods The H&E slides of 58 patients with residual prostate cancer after HIFU treatment were systematically reviewed. Correlation between the pathologist’s findings and immunohistochemical expression of MIB-1, alpha-Methyl-Co-Racemase and 34βE-12 staining was analyzed. Results Mean time from treatment to biopsy was 40.2 (8–208) weeks. The expert review of the H&E slides identified 40 patients with viable carcinoma in the post-HIFU biopsy cores. 18 patients were revised to necrosis-only-tumors. These biopsies were performed not later than 16 weeks after HIFU treatment (median 10.9 weeks, range 8–14). Both MIB-1 and AMACR staining displayed significant differential expression in viable carcinoma ( p  < 0.001) compared to necrosis tumors. Referring to viable carcinoma tissue, AMACR staining index was significantly rising, the longer treatment dated back from biopsy ( p  < 0.002). In this context, 34-β-E12 stained negative through all tumor areas and positive in the majority (85%) of the surrounding non-neoplastic epithelium. Conclusions AMACR and MIB-1 reliably differentiate viable carcinoma from a process of ongoing irreversible necrosis in early post-HIFU prostate biopsy cores and therefore proposed—in addition with 34 beta-E12—as useful markers exposing suspicious tumor foci in difficult cases.

Hintergrund Hochintensiver fokussierter Ultraschall (HIFU) wird seit Anfang der 90er Jahre als alternative Behandlungsform beim Prostatakarzinom eingesetzt. Ziel der Arbeit Übersicht über den aktuellen Stand und kritische Betrachtung der verschiedenen Indikationen des HIFU beim Prostatakarzinom. Material und Methoden Review der aktuellen Literatur zu Indikationen, Nebenwirkungen, onkologischen Ergebnissen und Leitlinienempfehlungen. Ergebnisse Das Prinzip basiert auf hochenergetischen Schallwellen, die durch Fokussierung zu einer Koagulationsnekrose führen. HIFU kann in unterschiedlichen Indikationen eingesetzt werden: beim Whole-gland-HIFU (Behandlung der kompletten Prostata) wird in der Primärtherapie des lokal begrenzten Prostatakarzinoms eine Ablation des kompletten Prostatagewebes angestrebt. Es liegen mehrere Fallserien mit einem maximalen medianen Follow-up von 8,1 Jahren vor. Die Hauptnebenwirkung ist die Ausbildung einer Blasenhalssklerose. Eine weitere Indikation ist der Salvage-HIFU bei Patienten mit Lokalrezidiv nach primärer Strahlentherapie. Aufgrund des erhöhten Risikos einer Inkontinenz sowie rektourethralen Fistelbildung muss die Indikation vorsichtig gestellt werden. Als innovative Feld gilt die fokale Therapie, bei welcher mithilfe des HIFU eine Teilbehandlung des tumortragenden Anteils der Prostata erfolgt. Durch technische Weiterentwicklungen ist eine Therapieplanung mit Fusion eines multiparametrischen Magnetresonanztomogramms (mpMRT) möglich. Aufgrund des experimentellen Charakters soll diese Therapieform in Studien erfolgen. Diskussion Aufgrund fehlender prospektiv randomisierter Studien sowie limitierter Langzeitdaten wird der Whole-gland-HIFU in den Leitlinien europäischer Länder unterschiedlich bewertet. Die fokale Therapie gilt als experimentell und soll daher nur in Studien durchgeführt werden.

Purpose To investigate cancer detection rates and percentage of tumour per core between real-time sonoelastography (RTE) targeted biopsy and lateralised tenfold random biopsy of the prostate in the primary and re-biopsy setting. Methods Patients undergoing primary or re-biopsy of the prostate were included. Systematic RTE (EUB 7500, Hitachi Medical Systems, Tokio, Japan) was performed with the patient in the left lateral position. A maximum of four RTE targeted biopsies of the peripheral zone were taken following by a lateralised tenfold biopsy done by a second investigator blinded to the RTE findings. RTE targeted and random biopsy cylinders from corresponding areas were compared for percentage of tumour per core. Chi-square test and Wilcoxon signed rank test were used to compare differences between different groups. Results One hundred and thirty-nine patients were included (52 with primary biopsy, 87 with re-biopsy). Prostate cancer was found in 73 (52.5%) patients. Cancer detection rates per core were 23.2% versus 9.2% and 21.9% versus 12.7% for RTE targeted and random biopsies in the primary and re-biopsy setting, which was statistically significant ( P  < 0.05). The mean percentage of prostate cancer per core from corresponding areas was significantly higher in RTE targeted compared to random biopsy cores with 21.5% versus 16.4% ( P  < 0.05). Conclusions RTE targeted biopsy significantly increases cancer detection rates per core in comparison with random biopsy. The difference is more pronounced in the primary biopsy setting. RTE targeted biopsy cores are of improved diagnostic value due significantly higher percentages of cancer compared to random biopsy cores.

The target of focal therapy (FT) in prostate cancer (PC) is partial treatment of the prostate aiming at preserving surrounding anatomical structures. The intention is to minimize typical side effects of radical treatment options combined with local tumor control. Numerous established and new technologies are used. Results of published studies showed a good safety profile, few side effects and good preservation of functional results. Oncologic long-term data are lacking so far. Photodynamic therapy (PDT) is the only technology that has been studied in a published prospective randomized trial. The FT is challenged by the multifocality of PC; therefore, the quality of prostate biopsy, histopathological assessment as well as imaging are of paramount importance. Multiparametric magnetic resonance imaging (MRI) has gained increasing importance. The FT is experimental and should only be offered within clinical trials.

Introduction In our series of 1,900 endoscopic extraperitoneal radical prostatectomies (EERPE) the incidence of symptomatic lymphocele following simultaneous pelvic lymph node dissection (PLND) is between 3 and 14% depending on the extent of lymph node dissection. We report the impact of bilateral peritoneal fenestration after completion of extraperitoneal prostatectomy and PLND on the incidence of lymphocele, postoperative pain and complications. Patients and methods A total of 100 consecutive patients undergoing EERPE and extended PLND were allocated into two groups. In Group A ( n  = 50) a 4–6 cm incision was performed bilaterally over the external iliac vessels down to the obturator fossa after completion of the main procedure. In Group B ( n  = 50) no peritoneal incisions were made. The postoperative assessment protocol included a visual analogue pain scale administered three times daily for 6 days, analgesia requirement, and ultrasound examination on 4th and 8th days, and 3 months postoperatively. CRP and leucocyte counts were measured on 1st and 2nd postoperative days. Complications were recorded according to our standard protocol using the Clavien classification. Results Three patients (6%) in Group A were found to have lymphoceles, none of which were symptomatic. Significantly more patients in Group B developed a lymphocele, ( n  = 16, 32%, P  < 0.001) of which a significant number were symptomatic ( n  = 7, 14%, P  < 0.001) and required laparoscopic fenestration. No significant difference was observed between the pain score in either group. Mean pain scores were 3.4 versus 3.8 at 6 h, and 0.8 versus 1.1 at 6 days, respectively. No difference in analgesia requirement, serum inflammatory markers and return to normal bowel activity was observed between the groups. Conclusions This study demonstrates that peritoneal fenestration significantly reduces the incidence of both symptomatic and asymptomatic lymphocele, without an increase in postoperative morbidity. As symptomatic lymphocele is one of the most common complications of extraperitoneal PLND requiring reintervention, we recommend that peritoneal fenestration should be performed routinely after extraperitoneal radical prostatectomy and PLND.